Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04526158
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2020-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Learning to Apply Mindfulness to Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'diana.burgess@va.gov', 'phone': '612-567-1591', 'title': 'Dr. Diana Burgess', 'organization': 'Minneapolis VAMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for each participant from the time they completed the baseline survey through their final follow-up survey time period. This is equal to approximately 16 months for each participant depending when exactly they completed each survey.', 'eventGroups': [{'id': 'EG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 0, 'seriousNumAtRisk': 270, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 0, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 0, 'seriousNumAtRisk': 270, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.6', 'pValueComment': 'significance threshold = 0.0167 due to multiple comparisons', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'pValueComment': 'significance threshold = 0.0167 due to multiple comparisons', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.4', 'pValueComment': 'significance threshold = 0.0167 due to multiple comparisons', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.\n\nChange in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.3', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.9', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.0', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function. Minimum value: 4. Maximum value: 20. Lower scores indicate worse physical functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.8', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors'}, {'pValue': '0.296', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety. Minimum value: 4. Maximum value: 20. Higher scores indicate worse anxiety. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.464', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.3', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of fatigue. Minimum value: 4. Maximum value: 20. Higher scores indicate worse fatigue. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.889', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors'}, {'pValue': '0.006', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of sleep disturbance. Minimum value: 4. Maximum value: 20. Higher scores indicate worse sleep disturbance. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.4', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.3', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'PROMIS-29 Profile v.2.0 measure of participation in social roles and activities. Minimum value: 4. Maximum value: 20. Lower scores indicate greater participation in social roles and activities. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.6', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.3', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.2', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient Health Questionnaire depression scale (PHQ8). Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.9', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '-0.4', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '-0.5', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5). Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.3', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.6', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors'}], 'paramType': 'MEAN', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Global impression of change scale from "much better" to "much worse". Minimum value: 1. Maximum value: 7. Higher scores indicate worse outcome. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BPI Interference Score Responder Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'OG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-13.9', 'ciUpperLimit': '-1.2', 'pValueComment': 'Used confidence interval to determine significance.', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '6.4', 'ciUpperLimit': '17.6', 'pValueComment': 'Used confidence interval to determine significance.', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.5', 'ciLowerLimit': '13.6', 'ciUpperLimit': '25.4', 'pValueComment': 'Used confidence interval to determine significance.', 'estimateComment': 'estimates were generated from multiple imputed data', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'FG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'FG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '271'}, {'groupId': 'FG002', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '225'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}, {'value': '811', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.\n\nMobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.'}, {'id': 'BG001', 'title': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.\n\nMobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.'}, {'id': 'BG002', 'title': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '54.6', 'spread': '12.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Operationalized as gender; woman, man', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '759', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}, {'value': '811', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-08', 'size': 947384, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-28T11:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The randomization list will be concealed from the research team within the tracking portal, so team members will not know the next study assignment. Permuted blocks will be used to aid in the concealment of treatment assignment while ensuring balance in treatment arms across time.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three arm parallel assignment design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 811}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2020-07-09', 'resultsFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.\n\nChange in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}], 'secondaryOutcomes': [{'measure': 'Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period.', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function. Minimum value: 4. Maximum value: 20. Lower scores indicate worse physical functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety. Minimum value: 4. Maximum value: 20. Higher scores indicate worse anxiety. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of fatigue. Minimum value: 4. Maximum value: 20. Higher scores indicate worse fatigue. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of sleep disturbance. Minimum value: 4. Maximum value: 20. Higher scores indicate worse sleep disturbance. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'PROMIS-29 Profile v.2.0 measure of participation in social roles and activities. Minimum value: 4. Maximum value: 20. Lower scores indicate greater participation in social roles and activities. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8)', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Patient Health Questionnaire depression scale (PHQ8). Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': "Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5)", 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5). Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}, {'measure': 'Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Global impression of change scale from "much better" to "much worse". Minimum value: 1. Maximum value: 7. Higher scores indicate worse outcome. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up.'}, {'measure': 'BPI Interference Score Responder Analysis', 'timeFrame': 'Weighted average over 10 weeks, 6 months, and 12 months.', 'description': 'Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Veteran', 'Chronic pain'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33313730', 'type': 'BACKGROUND', 'citation': 'Burgess DJ, Evans R, Allen KD, Bangerter A, Bronfort G, Cross LJ, Ferguson JE, Haley A, Hagel Campbell EM, Mahaffey MR, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S29-S36. doi: 10.1093/pm/pnaa337.'}, {'pmid': '39158851', 'type': 'BACKGROUND', 'citation': 'Burgess DJ, Calvert C, Hagel Campbell EM, Allen KD, Bangerter A, Behrens K, Branson M, Bronfort G, Cross LJS, Evans R, Ferguson JE, Friedman JK, Haley AC, Leininger B, Mahaffey M, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1163-1173. doi: 10.1001/jamainternmed.2024.3940.'}, {'pmid': '39514882', 'type': 'DERIVED', 'citation': 'Burgess DJ, Calvert C, Bangerter A, Branson M, Cross LJS, Evans R, Ferguson JE, Friedman JK, Hagel Campbell EM, Haley AC, Hennessy S, Kraft C, Mahaffey M, Matthias MS, Meis LA, Serpa JG, Taylor SL, Taylor BC. Do mindfulness interventions cause harm? Findings from the Learning to Apply Mindfulness to Pain (LAMP) Pragmatic Clinical Trial. Pain Med. 2024 Nov 1;25(Supplement_1):S68-S76. doi: 10.1093/pm/pnae056.'}, {'pmid': '39030622', 'type': 'DERIVED', 'citation': 'Ferguson JE, Hagel Campbell E, Bangerter A, Cross LJS, Allen KD, Behrens K, Branson M, Calvert C, Friedman JK, Hennessy S, Meis LA, Taylor BC, Burgess DJ. Email recruitment for chronic pain clinical trials: results from the LAMP trial. Trials. 2024 Jul 19;25(1):491. doi: 10.1186/s13063-024-08301-8.'}, {'pmid': '38404673', 'type': 'DERIVED', 'citation': 'Burgess DJ, Hagel Campbell EM, Branson M, Calvert C, Evans R, Allen KD, Bangerter A, Cross LJS, Driscoll MA, Hennessy S, Ferguson JE, Friedman JK, Matthias MS, Meis LA, Polusny MA, Taylor SL, Taylor BC. Exploring Gender Differences in Veterans in a Secondary Analysis of a Randomized Controlled Trial of Mindfulness for Chronic Pain. Womens Health Rep (New Rochelle). 2024 Feb 12;5(1):82-92. doi: 10.1089/whr.2023.0086. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The long-term goal of this two-phase project is to reduce chronic pain and co-morbid conditions among Veterans, through scalable, non-pharmacologic evidence-based strategies that are "Veteran-Centric," designed to optimize engagement, adherence and sustainability, and are deliverable to large numbers of Veterans.', 'detailedDescription': 'The investigators will conduct a 3-site 3-arm pragmatic clinical trial (N = 750) to test effectiveness of 2 Mindfulness-Based Interventions (MBIs), Mobile+Group LAMP and Mobile LAMP, compared to usual practice. Effectiveness will be assessed by pain functioning over the 12-month follow-up period using the Brief Pain Inventory (BPI) interference score. The investigators will test the following primary hypotheses: (1) Mobile LAMP will be more effective at improving chronic pain (as measured by change in the BPI interference score over the 12-month follow-up period) compared to usual practice, (2) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference score over the 12-month follow-up period) compared to usual practice, and (3) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference change over the 12-month follow-up period) compared to Mobile LAMP without the group component. The investigators will test the following secondary hypotheses: (1) Comparison of intervention group with secondary outcomes listed below, and (2) primary and secondary hypotheses comparisons will be confirmed in gender-specific strata. The primary outcome will be measured as change in BPI interference score over the 12-month follow-up period. Secondary outcomes will include patient-reported measures related to pain, comorbid mental health conditions and function, expected mediators of treatment effects, patient satisfaction, and adverse effects and measures captured in electronic health records. These outcomes will be assessed at 10 weeks, 6 months and 12 months. Implementation data will be collected and described, using the guided Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have qualifying pain diagnoses on at least 2 occasions, at least 90 days apart, within the same pain category, during the previous 2 years\n* Must report having a pain duration of ≥ 6 months (pain chronicity threshold), and a pain severity score of ≥ 4 on the 0-10 Numeric Rating Scale (pain severity threshold).\n* Must have access to a smart phone that meets the requirement of the mobile app software\n* Must be willing and able to download the mobile app on their phone\n* Must have wireless or cellular internet access on a daily basis\n* Must be willing to meet via video conference on the dates and at the time when Mobile+Group LAMP sessions are held, and attend all sessions of the arm to which they are randomized.\n\nExclusion Criteria:\n\n* new diagnosis of schizophrenia, bipolar disorder, major depressive disorder, or other psychosis within the past 18 months; or current active psychotic symptoms, suicidality, severe depression, manic episode, and/or poorly controlled bipolar disorder (as assessed by a medical chart review)\n* currently enrolled in a research study for pain\n* currently enrolled in mindfulness-based stress reduction (MBSR)'}, 'identificationModule': {'nctId': 'NCT04526158', 'acronym': 'LAMP', 'briefTitle': 'Learning to Apply Mindfulness to Pain', 'organization': {'class': 'FED', 'fullName': 'United States Department of Defense'}, 'officialTitle': 'Testing Two Scalable, Veteran-centric Mindfulness-based Interventions for Chronic Musculoskeletal Pain: A Pragmatic, Multisite Trial', 'orgStudyIdInfo': {'id': '#NH170001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'description': '8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.', 'interventionNames': ['Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile LAMP Mindfulness-Based Intervention', 'description': '8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.', 'interventionNames': ['Behavioral: Mobile LAMP Mindfulness-Based Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.'}], 'interventions': [{'name': 'Mobile+Group LAMP Mindfulness-Based Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Mobile+Group LAMP'], 'description': 'The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.', 'armGroupLabels': ['Mobile+Group LAMP Mindfulness-Based Intervention']}, {'name': 'Mobile LAMP Mindfulness-Based Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Mobile LAMP'], 'description': 'The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.', 'armGroupLabels': ['Mobile LAMP Mindfulness-Based Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Veteran Administration Health Care System', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Department of Defense', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diana J. Burgess', 'investigatorAffiliation': 'Minneapolis Veterans Affairs Medical Center'}}}}