Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT05098158
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Community-Engaged Options to Facilitate Opioid Reduction
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': 'marian.wilson@wsu.edu', 'phone': '509-324-7443', 'title': 'Marian Wilson', 'organization': 'Washington State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Severity of event was rated as (select one): Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe Participants were evaluated by RN as to whether there was a reasonable possibility that the experimental COMFORT intervention caused the event.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild', 'notes': 'Vertigo reported by participant; does not believe it was related to the study intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '6.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.9', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'PRIMARY', 'title': 'PROMIS Pain Interference Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.9', 'spread': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '8.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.6', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.1', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'PROMIS Self-efficacy for Managing Symptoms Short Form 4a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.168', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.9', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'PROMIS Self-efficacy for Managing Emotions Short Form 4a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.456', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.1', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'Anxiety Using Generalized Anxiety Disorder (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Participants with pre and post data for analysis'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '5.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.517', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.8', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '7-item scale with score range 0-21 (higher score is worsened anxiety)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'Interpersonal Needs Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Participants with pre and post data for analysis'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '13.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.2', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'Current Opioid Misuse Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Participants with pre and post data for analysis'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.811', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.3', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'SECONDARY', 'title': 'Spiritual Well-being Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Participants with pre and post data for analysis'}], 'classes': [{'title': 'Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.941', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1', 'pValueComment': 'Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data', 'groupDescription': 'Paired t tests of pre and posttest dat', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post data for analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Attendance in Scheduled Telehealth Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'telehealth sessions', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '95.8', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics to report the percentage of offered telehealth sessions that were attended \\[#attended/#offered = % attended\\]'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)', 'unitOfMeasure': 'percentage of sessions attended', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'telehealth sessions', 'denomUnitsSelected': 'telehealth sessions', 'populationDescription': 'All participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'IBM Computer Usability and Satisfaction Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Participants with pre and post data for analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '6.59', 'spread': '0.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.', 'unitOfMeasure': 'mean of summed scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with satisfaction data completed - 1 did not participate'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Yoga Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Physical Therapy Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Massage Intevention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Chiropractic Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Pain Treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks\n\nNon-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', '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': '15', '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': '1', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', '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': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PROMIS Pain Intensity Scale', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-15', 'size': 5015618, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-05-01T18:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group studied over 6 weeks time'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2020-07-13', 'resultsFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Attendance in Scheduled Telehealth Sessions', 'timeFrame': '6 weeks', 'description': 'Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)'}, {'measure': 'IBM Computer Usability and Satisfaction Questionnaires', 'timeFrame': '6 weeks', 'description': 'The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.'}], 'primaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating', 'timeFrame': '6 weeks', 'description': 'Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion).'}, {'measure': 'PROMIS Pain Interference Rating', 'timeFrame': '6 weeks', 'description': 'Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)', 'timeFrame': '6 weeks', 'description': 'Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)'}, {'measure': 'PROMIS Self-efficacy for Managing Symptoms Short Form 4a', 'timeFrame': '6 weeks', 'description': 'Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion).'}, {'measure': 'PROMIS Self-efficacy for Managing Emotions Short Form 4a', 'timeFrame': '6 weeks', 'description': 'Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion).'}, {'measure': 'Anxiety Using Generalized Anxiety Disorder (GAD-7)', 'timeFrame': '6 weeks', 'description': '7-item scale with score range 0-21 (higher score is worsened anxiety)'}, {'measure': 'Interpersonal Needs Questionnaire', 'timeFrame': '6 weeks', 'description': '9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)'}, {'measure': 'Current Opioid Misuse Measure', 'timeFrame': '6 weeks', 'description': '17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)'}, {'measure': 'Spiritual Well-being Index', 'timeFrame': '6 weeks', 'description': '4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'opioid', 'complementary'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.', 'detailedDescription': 'Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrollment in treatment at the CHAS Perry St or partnering clinic;\n* age greater than 18 years;\n* ability to read, speak, and write English;\n* diagnosed with a chronic, non-cancer-based painful medical condition;\n* ability to provide informed consent.\n\nExclusion Criteria:\n\n* pregnancy;\n* diagnosis of a cancer-based painful medical condition;\n* any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)'}, 'identificationModule': {'nctId': 'NCT05098158', 'acronym': 'COMFORT', 'briefTitle': 'Community-Engaged Options to Facilitate Opioid Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Washington State University'}, 'officialTitle': 'Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment', 'orgStudyIdInfo': {'id': '18111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm pain treatment', 'description': 'Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks', 'interventionNames': ['Other: Non-pharmacological pain treatment']}], 'interventions': [{'name': 'Non-pharmacological pain treatment', 'type': 'OTHER', 'description': 'Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.', 'armGroupLabels': ['Single arm pain treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99201', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Community Health Association of Spokane', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '99201', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Washington State University College of Nursing', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spokane Regional Health District', 'class': 'UNKNOWN'}, {'name': 'University of Washington Institute for Translational Health Science (KL2)', 'class': 'OTHER'}, {'name': 'Rayce Rudeen Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marian Wilson', 'investigatorAffiliation': 'Washington State University'}}}}