Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT03495856
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
4-week Mindfulness Program for Adults With Chronic 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': 'carrie_brintz@med.unc.edu', 'phone': '919-445-6109', 'title': 'Carrie Brintz', 'organization': 'University of North Carolina School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks (session 1 through session 4)', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Distress due to potential for dissociating', 'notes': 'Participant felt like might dissociate during mindfulness meditation practice (had past history of a dissociative disorder). Resulted in distress, which was resolved during the course of the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility - Study Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Proportion of participants enrolled who completed the study', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who enrolled and completed the baseline assessment'}, {'type': 'PRIMARY', 'title': 'Feasibility - Session Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.96'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (intervention weeks 1-4)', 'description': 'Average sessions attended (proportion)', 'unitOfMeasure': 'Proportion of sessions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Credibility and Expectancy Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'How logical is the mindfulness program', 'categories': [{'measurements': [{'value': '6.4', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Confidence that program will improve chronic pain', 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Confidence in recommending program to friend', 'categories': [{'measurements': [{'value': '6.4', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'How important we make this available to others', 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Believe program would decrease other problems?', 'categories': [{'measurements': [{'value': '7.6', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intervention week 2', 'description': 'Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 \\[not at all\\] to 10 \\[very\\]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the measure after session 2 (week 2)'}, {'type': 'PRIMARY', 'title': 'Acceptability - Intervention Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Slightly dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Neutral', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Slightly satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderately satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (within one week post-intervention)', 'description': 'Question assessing participants satisfaction with the intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the post-assessment'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '5.91', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '5.14', 'spread': '1.86', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.00', 'pValueComment': 'The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.37', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post-assessments'}, {'type': 'SECONDARY', 'title': 'Pain Interference Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '63.76', 'spread': '7.31', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '60.10', 'spread': '5.65', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.67', 'ciLowerLimit': '-6.63', 'ciUpperLimit': '-0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'SECONDARY', 'title': 'Physical Functioning Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '38.17', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '38.22', 'spread': '6.81', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.938', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '1.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'SECONDARY', 'title': 'Depression Short-Form 4a Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '56.82', 'spread': '9.75', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '53.49', 'spread': '8.62', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.34', 'ciLowerLimit': '-5.53', 'ciUpperLimit': '-1.15', 'pValueComment': 'The a priori threshold for statistical significance was p less than or equal to 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'SECONDARY', 'title': 'Anxiety Short-Form 4a Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '59.06', 'spread': '9.44', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '56.84', 'spread': '8.02', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.124', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.21', 'ciLowerLimit': '-5.09', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'SECONDARY', 'title': 'Sleep Disturbance Short-Form 4a Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '56.52', 'spread': '7.79', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '51.83', 'spread': '9.75', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.69', 'ciLowerLimit': '-7.30', 'ciUpperLimit': '-2.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post-assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Stress Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '7.23', 'spread': '3.70', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '5.95', 'spread': '3.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-2.31', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Positive Affect and Well-being Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '47.86', 'spread': '7.41', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '50.66', 'spread': '7.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.79', 'ciLowerLimit': '0.58', 'ciUpperLimit': '5.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.07', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain Catastrophizing Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '23.64', 'spread': '12.79', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '18.68', 'spread': '12.38', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.96', 'ciLowerLimit': '-7.88', 'ciUpperLimit': '-2.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Chronic Pain Acceptance Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '57.64', 'spread': '4.22', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '70.91', 'spread': '4.46', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.27', 'ciLowerLimit': '8.47', 'ciUpperLimit': '18.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trait Mindfulness Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '34.23', 'spread': '12.79', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '42.23', 'spread': '8.10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.00', 'ciLowerLimit': '3.92', 'ciUpperLimit': '12.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.96', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Within-group paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline and post assessments'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment Dates: April 2018 to September 2018 Recruitment Setting: Medical clinics; University/Medical center campus and email listserve'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Training', 'description': '4-week mindfulness skills group for adults with chronic pain'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.00', 'spread': '15.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years with chronic pain', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Less than high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'High School diploma or equivalent', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Some college, no college degree', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'College degree or greater', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Yearly Household Income', 'classes': [{'categories': [{'title': 'Less than $20,000', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '$20,000 to 39,999', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '$40,000 to $59,999', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '$60,000 to $79,999', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '$80,000 +', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Source/location of pain', 'classes': [{'title': 'Back', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Arthritis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Fibromyalgia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Neck', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Neuropathy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Headache/migraine', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Pelvic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis includes all 23 participants who enrolled and completed the baseline assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-09', 'size': 501287, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-15T10:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-group, mixed methods repeated measures design (pre and post assessments)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2018-03-21', 'resultsFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-30', 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perceived Stress Scale Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.'}, {'measure': 'Positive Affect and Well-being Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.'}, {'measure': 'Pain Catastrophizing Scale Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.'}, {'measure': 'Chronic Pain Acceptance Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.'}, {'measure': 'Trait Mindfulness Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.'}], 'primaryOutcomes': [{'measure': 'Feasibility - Study Retention', 'timeFrame': '4 weeks', 'description': 'Proportion of participants enrolled who completed the study'}, {'measure': 'Feasibility - Session Attendance', 'timeFrame': '4 weeks (intervention weeks 1-4)', 'description': 'Average sessions attended (proportion)'}, {'measure': 'Credibility and Expectancy Questionnaire Scores', 'timeFrame': 'Intervention week 2', 'description': 'Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 \\[not at all\\] to 10 \\[very\\]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.'}, {'measure': 'Acceptability - Intervention Satisfaction', 'timeFrame': '4 weeks (within one week post-intervention)', 'description': 'Question assessing participants satisfaction with the intervention'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.'}, {'measure': 'Pain Interference Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome.'}, {'measure': 'Physical Functioning Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome.'}, {'measure': 'Depression Short-Form 4a Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome.'}, {'measure': 'Anxiety Short-Form 4a Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome.'}, {'measure': 'Sleep Disturbance Short-Form 4a Scores', 'timeFrame': 'Baseline and 4 weeks (pre to post-intervention)', 'description': 'Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness-based stress reduction', 'Mindfulness', 'chronic pain', 'Feasibility', 'Intervention'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '38434590', 'type': 'DERIVED', 'citation': 'Brintz CE, Polser G, Coronado RA, French B, Faurot KR, Gaylord SA. Are Formal and Informal Home Mindfulness Practice Quantities Associated With Outcomes? Results From a Pilot Study of a Four-Week Mindfulness Intervention for Chronic Pain Management. Glob Adv Integr Med Health. 2024 Feb 29;13:27536130241236775. doi: 10.1177/27536130241236775. eCollection 2024 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One or more chronic noncancer pain diagnoses (daily pain for at least 3 months)\n* Has a pain management provider\n* Reports more than minimal pain bothersomeness and interference in general activities\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Diagnosis of mental illness with psychotic features\n* History of inpatient admission for psychiatric disorder in past 2 years\n* Active alcohol or substance abuse within the past year\n* Has completed a mindfulness-based stress reduction or other mindfulness course; has or previously had a regular mindfulness meditation practice.\n* Unable or unwilling to comply with study procedures (online questionnaires and practice diaries, 4 weekly intervention sessions, home practice, and one semi-structured phone interview).'}, 'identificationModule': {'nctId': 'NCT03495856', 'briefTitle': '4-week Mindfulness Program for Adults With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain', 'orgStudyIdInfo': {'id': '17-2948'}, 'secondaryIdInfos': [{'id': '2KR941702', 'type': 'OTHER_GRANT', 'domain': 'North Carolina Translational and Clinical Sciences Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Training For Chronic Pain', 'description': 'The intervention is adapted from the mindfulness-based stress reduction program. The adapted mindfulness training program consists of four, weekly 90 minute group sessions that focus on education on chronic pain and mindfulness, instruction and in-class mindfulness skills practice, and group discussion.', 'interventionNames': ['Behavioral: Mindfulness Training For Chronic Pain']}], 'interventions': [{'name': 'Mindfulness Training For Chronic Pain', 'type': 'BEHAVIORAL', 'description': '4-week group Mindfulness training program for adults with chronic pain', 'armGroupLabels': ['Mindfulness Training For Chronic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Carrie Brintz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}