Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-03 @ 3:25 AM
Study NCT ID:
NCT03699020
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2018-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm1young@health.ucsd.edu', 'phone': '1-619-543-5039', 'title': 'Maile Young Karris', 'organization': 'University of California San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We hypothesize our ability to recruit and engage participants was impaired by the COVID-19 pandemic. Barriers included halting of non-covid studies, IRB approval for remote delivery of the intervention, disinterest in research participation in the context of COVID, lack of access to reliable internet connectivity and unfamiliarity with video visits.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Adverse events would be defined as events reported by participants and study staff', 'eventGroups': [{'id': 'EG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education Control', 'description': 'Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of six weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'OG001', 'title': 'Education Control', 'description': 'Consists of six weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 6.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of six weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'OG001', 'title': 'Education Control', 'description': 'Consists of six weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '6.25'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 weeks', 'description': 'Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 3.', 'unitOfMeasure': 'change in score from 0 to 6 weeks.', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory Interference Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of six weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'OG001', 'title': 'Education Control', 'description': 'Consists of six weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'groupId': 'OG000', 'lowerLimit': '-2.57', 'upperLimit': '-0.86'}, {'value': '-0.14', 'groupId': 'OG001', 'lowerLimit': '-1.21', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 6. The BPI allows persons to rate the severity of their pain (pain severity subscale) and the degree to which their pain interferes with feeling and function (interference subscale). The severity scale assess pain at its "worst, least, average and now". These 4 items are ranked from 0 (no pain) to 10 (pain as bad as you can imagine). Most commonly single items of "worst" and "average" are used to represent severity. A composite of the four items (mean severity score) is often also presented. Pain interference has 7 items "general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life" and is scored from 0 (does not interfere) to 10 (completely interferes). Pain interference subscale is scored as the mean of the seven interference items. Change in BPI interference subscale will be represented by the difference in mean interference from baseline to week 6.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Education Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of six weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'OG001', 'title': 'Education Control', 'description': 'Consists of six weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.075', 'upperLimit': '0.175'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.', 'unitOfMeasure': 'proportion of correct answers', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'FG001', 'title': 'Education Control', 'description': 'Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Intervention Attendance Completion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'All participants were randomized to groups shortly after enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.\n\nAcceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.'}, {'id': 'BG001', 'title': 'Education Control', 'description': 'Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.\n\nChronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '57.5', 'upperLimit': '66.5'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '62'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '62.25'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years living with HIV', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '22.5', 'upperLimit': '24'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '33'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '27.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Years participant has been living with HIV. Participant reported, at least from date of diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Years on antiretroviral therapy', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '22.5', 'upperLimit': '24'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '24'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '19.3', 'upperLimit': '24.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Years that participant has been taking antiretroviral therapy for HIV', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Current HIV Viral Load', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '184'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'description': 'Viral load is measured in blood and represented as "x" copies/mL. Of note we used "0" for undetectable or \\< 20 copies/mL', 'unitOfMeasure': 'HIV copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Current CD4 T cell count', 'classes': [{'categories': [{'measurements': [{'value': '716', 'groupId': 'BG000', 'lowerLimit': '639', 'upperLimit': '1007'}, {'value': '1051', 'groupId': 'BG001', 'lowerLimit': '408', 'upperLimit': '1161'}, {'value': '1051', 'groupId': 'BG002', 'lowerLimit': '513.8', 'upperLimit': '1053.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'CD4+ T cells, total number of cells per m3', 'unitOfMeasure': 'cells/m3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Veterans Aging Cohort Study Index', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '34'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '39'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '15.8', 'upperLimit': '37.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'The VACS 1.0 Index characterize the 5 year mortality risk in people with HIV. This Index incorporates age, CD4 T cell count, HIV-1 RNA, hemoglobin, Fib-4 index, eGRF, and Hepatitis C coinfection to create a total score (score range 0 to 164). A score of 0 equates to 1.8% predicted all cause 5-year mortality; a 164 has \\>85.8% predicted all cause 5-year mortality. This means the higher the VACS index the higher the probability of 5-year mortality due to all causes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total # pain medications', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'We added unique medications (prescribed and over the counter) that participants stated they used daily for pain management including opioids, muscle relaxants, medications for neuropathy, NSAIDS, acetaminophen etc.', 'unitOfMeasure': 'number of medications', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total # of opioid/opiates prescribed', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0.25'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0.25', 'upperLimit': '0.75'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0.75'}]}]}], 'paramType': 'MEDIAN', 'description': 'Total number of unique prescribed opioid/opiates participants were taking. We did not calculate morphine miligram equivalents.', 'unitOfMeasure': 'total # of opioid/opiates prescribed', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline CPAQ-R Activity Engagement', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '53'}, {'value': '25.5', 'groupId': 'BG001', 'lowerLimit': '21.8', 'upperLimit': '28.8'}, {'value': '34', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'description': 'The 20 item Chronic Pain Acceptance Questionnaire-Revised measures acceptance of pain. There are two factors 1) activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance\n\nThe activity engagement scale has 11 items each rated from 0 (never true) to 6 (always true). Scores are added and the range of the activity engagement scale is 0 (no acceptance of pain) to 66 (high acceptance of pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline CPAQ-R Pain Willingness', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '20.5', 'upperLimit': '40.5'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '31.3', 'upperLimit': '33.5'}, {'value': '32', 'groupId': 'BG002', 'lowerLimit': '26.5', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'description': 'The 20 item Chronic Pain Acceptance Questionnaire-Revised measures acceptance of pain in regards to 1) activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance\n\nThe pain willingness scale includes 9 items and all items are rated from 0 (never true) to 6 (always true). Scores are added and the range is 0 (no acceptance of pain) to 54 (high acceptance of pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline CPAQ-R (revised) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '76'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '55.3', 'upperLimit': '58.5'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '60.5', 'upperLimit': '69.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The 20 item Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) is designed to measure acceptance of pain. There are two factors identified 1) Activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance. Range is 0 (no acceptance) to 120 (high acceptance)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Brief Pain Inventory: Pain Severity (worse)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '7.5', 'upperLimit': '9.5'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5.75', 'upperLimit': '6.5'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '6.5', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Brief Pain Inventory (BPI) short form measures two domains 1) pain intensity (severity) and 2) the impact of pain on functioning (interference). The BPI does not have a scoring algorithm. Most researcher use ratings of "worse" and "average" pain scores to describe pain intensity. The range is from 0 (no pain) to 10 (pain as bad as you can imagine.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Brief Pain Inventory: Pain Severity (average)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '9'}, {'value': '4.5', 'groupId': 'BG001', 'lowerLimit': '3.25', 'upperLimit': '5.5'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Brief Pain Inventory (BPI) short form measures two domains 1) pain intensity (severity) and 2) the impact of pain on functioning (interference). The BPI does not have a scoring algorithm. Most researcher use ratings of "worse" and "average" pain scores to describe pain intensity. The range is from 0 (no pain) to 10 (pain as bad as you can imagine.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Brief Pain Inventory: Pain interference', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '7.5'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '4.1', 'upperLimit': '5.8'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Brief Pain Inventory short form also measures the impact of pain on functioning (interference). Seven questions inquire about the how much pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each of these areas are scored from 0 (does not interfere) to 10 (completely interferes). Pain interference is reported as a mean of these 7 unique areas.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pain Knowledge Test % Correct', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '85'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '67.5', 'upperLimit': '82.5'}, {'value': '80', 'groupId': 'BG002', 'lowerLimit': '70', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'description': 'To evaluate the impact or not of the control (pain education) a general pain knowledge test was provided to all participants. We then provide the median of the % of questions that participants answered correctly on the test.', 'unitOfMeasure': '% questions answered correctly', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'These participants were randomized, however once the intervention or control started several participants opted to no longer continue'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-22', 'size': 372693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-05T12:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2018-07-12', 'resultsFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-31', 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6', 'timeFrame': '6 weeks', 'description': 'Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 6.'}], 'secondaryOutcomes': [{'measure': 'Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3', 'timeFrame': '3 weeks', 'description': 'Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 3.'}, {'measure': 'Brief Pain Inventory Interference Subscale', 'timeFrame': '6 weeks', 'description': 'Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 6. The BPI allows persons to rate the severity of their pain (pain severity subscale) and the degree to which their pain interferes with feeling and function (interference subscale). The severity scale assess pain at its "worst, least, average and now". These 4 items are ranked from 0 (no pain) to 10 (pain as bad as you can imagine). Most commonly single items of "worst" and "average" are used to represent severity. A composite of the four items (mean severity score) is often also presented. Pain interference has 7 items "general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life" and is scored from 0 (does not interfere) to 10 (completely interferes). Pain interference subscale is scored as the mean of the seven interference items. Change in BPI interference subscale will be represented by the difference in mean interference from baseline to week 6.'}, {'measure': 'Change in Pain Education Score', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Chronic Pain', 'Acceptance and Commitment Therapy', 'Behavioral Intervention', 'Older Adults'], 'conditions': ['HIV/AIDS', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '22115794', 'type': 'BACKGROUND', 'citation': 'Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. 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Cogn Behav Pract. 2013 Feb;20(1):47-56. doi: 10.1016/j.cbpra.2011.07.004.'}, {'pmid': '21732897', 'type': 'BACKGROUND', 'citation': 'Moitra E, Herbert JD, Forman EM. Acceptance-based behavior therapy to promote HIV medication adherence. AIDS Care. 2011 Dec;23(12):1660-7. doi: 10.1080/09540121.2011.579945. Epub 2011 Jul 7.'}, {'pmid': '22523308', 'type': 'BACKGROUND', 'citation': 'Chen EK, Reid MC, Parker SJ, Pillemer K. Tailoring evidence-based interventions for new populations: a method for program adaptation through community engagement. Eval Health Prof. 2013 Mar;36(1):73-92. doi: 10.1177/0163278712442536. Epub 2012 Apr 19.'}, {'pmid': '18562251', 'type': 'BACKGROUND', 'citation': 'McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Chronic pain impacts a large proportion of aging people living with HIV (aPLWH) and involves factors directly related to HIV (neurotoxicity) and psychosocial co-morbidities common in aPLWH (i.e. social isolation and loneliness). The investigators hypothesize that novel interventions that acknowledge these psychosocial co-morbidities may improve the efficacy of chronic pain management and minimize the use of potentially dangerous medications. This grant proposes to adapt and pilot a pain psychotherapy approach using group acceptance and commitment therapy (ACT) in aPLWH with chronic pain.', 'detailedDescription': 'Chronic pain affects a very high proportion of aging people living with HIV (aPLWH) and is thought to be related to both direct toxicity of HIV and antiretroviral therapy (ART) and by psychosocial factors that negatively affect pain (i.e. loneliness, HIV stigma). PLWH are also at increased risk for prescription opiate misuse. However as PLWH age, non-opiate medications used for pain can contribute to other negative outcomes such as falls, altered mental status and gastrointestinal bleeding. Thus there is a critical need for the development of novel interventions in the management of chronic pain in aPLWH that consider the psychological co-morbidities of aging with HIV and that can minimize the need for prescription medications. Acceptance and commitment therapy (ACT) has previously been evaluated in older persons with chronic pain and has demonstrated higher levels of satisfaction and efficacy when compared to cognitive behavioral therapy (CBT). ACT has never been evaluated in aPLWH for chronic pain, but has theoretical advantages over CBT for this population. Specifically several negatively modifying factors of CBT efficacy such as cognitive deficits are common in aPLWH.\n\nThe overarching objective of this study is to determine the acceptability and feasibility of an ACT intervention for the management of chronic pain adapted to aPLWH. To accomplish this objective the investigators will 1) train lay personnel to perform ACT to determine feasibility of this approach for future implementation, 2) conduct uncontrolled group ACT in aPLWH to generate participant feedback and questionnaire data to inform ACT adaption with the assistance of a steering commitee, and 3) conduct a pilot randomized controlled trial (RCT) evaluating the acceptability of adapted ACT compared to pain education. At completion of this grant the investigators expect to have successfully trained lay personnel to perform group ACT, adapted ACT from quantitative and qualitative data collected from an uncontrolled study of group ACT, and determined whether ACT is acceptable and feasible as an intervention in aPLWH. These expected outcomes may benefit other aging populations with chronic pain that are enriched for psychosocial co-morbidities such as persons who inject drugs, the socioeconomically disadvantaged, and racial or gender minorities. This proposal is aligned with the Office of AIDS Research High Priorities to better understand "HIV-associated comorbidities" which includes pain and to "Reduce Health Disparities in treatment outcomes of those living with HIV/AIDS" and with the National Pain Strategy to "expand investment ... in the development of safe and effective pain treatments."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV seropositive\n* Diagnosis of chronic non cancer pain\n* English speaking\n* Deemed appropriate for study by primary care provider\n* Consents to participation\n\nExclusion Criteria:\n\n* Cancer associated pain\n* Unwillingness to participate in audio recorded sessions\n* Enrollment in hospice\n* Moderate to severe neurocognitive deficits (MOCA \\< 16)\n* Currently undergoing other psychotherapy for chronic pain'}, 'identificationModule': {'nctId': 'NCT03699020', 'briefTitle': 'Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Acceptance and Commitment Therapy to Address the Psychosocial Co-Morbidities of Chronic Pain in Aging People Living With HIV', 'orgStudyIdInfo': {'id': '180837'}, 'secondaryIdInfos': [{'id': '1R03AG060183-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03AG060183-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy (ACT)', 'description': 'The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy (ACT)']}, {'type': 'EXPERIMENTAL', 'label': 'Education Control', 'description': 'Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.', 'interventionNames': ['Other: Chronic Pain Education']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.', 'armGroupLabels': ['Acceptance and Commitment Therapy (ACT)']}, {'name': 'Chronic Pain Education', 'type': 'OTHER', 'description': 'Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life', 'armGroupLabels': ['Education Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103-8208', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'AntiViral Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available twelve months after study has ended and for five years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data including quantitative (questionnaires, baseline data) and qualitative (focus group) data will be stored in our secure database and made available to researchers upon request.', 'accessCriteria': 'Contact PI and submission of brief proposal to minimize duplication of effort and ensure research questions are answerable using IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maile Young Karris', 'investigatorAffiliation': 'University of California, San Diego'}}}}