Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 11:42 AM
Study NCT ID:
NCT04943432
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040261', 'term': 'Harm Reduction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cpaq@live.unc.edu', 'phone': '919-962-5082', 'title': 'Catherine Paquette, MA, MPS', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of informed consent through the 1-month follow-up assessment, a period of up to 3 months (where average duration was approximately 2 months).', 'eventGroups': [{'id': 'EG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.00', 'spread': '28.93', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.75', 'spread': '36.12', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.67', 'spread': '17.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000'], 'groupDescription': 'T2 - T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.68', 'groupIds': ['OG000'], 'groupDescription': 'T3 - T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'PRIMARY', 'title': 'Change in Substance Use Problem Recognition Score Assessed With Recognition Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.82', 'spread': '4.80', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.25', 'spread': '4.04', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.17', 'spread': '4.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Outcome is subscale score on Recognition subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 7-35, higher scores indicate greater problem recognition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'PRIMARY', 'title': 'Change in Taking Steps to Change Substance Use Assessed With Taking Steps Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.28', 'spread': '6.77', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.62', 'spread': '6.39', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.91', 'spread': '6.60', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.32', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Outcome is subscale score on Taking Steps subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 8-40, higher scores indicate greater steps to change (positive outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'PRIMARY', 'title': 'Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.92', 'spread': '11.90', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.08', 'spread': '12.55', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.34', 'spread': '11.22', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.44', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.007', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'PRIMARY', 'title': 'Treatment Attendance (Feasibility)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Participants who attended at least one session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)', 'unitOfMeasure': 'Treatment sessions attended', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who enrolled in the study'}, {'type': 'PRIMARY', 'title': 'Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'PRIMARY', 'title': 'Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'SECONDARY', 'title': 'Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.17', 'spread': '9.54', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.73', 'spread': '9.37', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.14', 'spread': '8.07', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.11', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.14', 'spread': '7.46', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.31', 'spread': '6.86', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.22', 'spread': '7.56', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.82', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.36', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'SECONDARY', 'title': 'Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.61', 'spread': '6.20', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.25', 'spread': '7.78', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '5.52', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.34', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.02', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'SECONDARY', 'title': 'Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'timeFrame': 'from Pretreatment up to 2 months posttreatment', 'description': 'Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are not available for this outcome due to a survey programming error resulting in invalid data for the ASSIST.'}, {'type': 'SECONDARY', 'title': 'Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.46', 'spread': '8.27', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.28', 'spread': '27.47', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.13', 'spread': '31.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.29', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}, {'type': 'SECONDARY', 'title': 'Goal Attainment Assessed With Modified Goal Attainment Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'timeFrame': 'During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks', 'description': 'Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was dropped (never added to the survey) as it was not one of the primary or secondary outcomes delineated in the study protocol. Data for this measure were not collected.'}, {'type': 'SECONDARY', 'title': 'Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'classes': [{'title': 'T1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.50', 'spread': '6.52', 'groupId': 'OG000'}]}]}, {'title': 'T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '5.79', 'groupId': 'OG000'}]}]}, {'title': 'T3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.80', 'spread': '6.53', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'T2-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.23', 'groupIds': ['OG000'], 'groupDescription': 'T3-T1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are included for all participants who provided valid assessment data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention\n\nBehavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'People Who Inject Drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '7.8', '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': '11', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', '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'}], 'populationDescription': 'Participants who completed the pretreatment assessment and enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-28', 'size': 351166, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-10T12:10', 'hasProtocol': True}, {'date': '2021-05-14', 'size': 197489, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-16T18:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-02', 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).'}, {'measure': 'Change in Substance Use Problem Recognition Score Assessed With Recognition Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Outcome is subscale score on Recognition subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 7-35, higher scores indicate greater problem recognition.'}, {'measure': 'Change in Taking Steps to Change Substance Use Assessed With Taking Steps Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Outcome is subscale score on Taking Steps subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 8-40, higher scores indicate greater steps to change (positive outcome)'}, {'measure': 'Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)'}, {'measure': 'Treatment Attendance (Feasibility)', 'timeFrame': 'During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)'}, {'measure': 'Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)', 'timeFrame': 'At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)'}, {'measure': 'Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)', 'timeFrame': 'At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks', 'description': 'Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)'}], 'secondaryOutcomes': [{'measure': 'Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)'}, {'measure': 'Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)'}, {'measure': 'Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)'}, {'measure': 'Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score', 'timeFrame': 'from Pretreatment up to 2 months posttreatment', 'description': 'Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)'}, {'measure': 'Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)'}, {'measure': 'Goal Attainment Assessed With Modified Goal Attainment Scale Score', 'timeFrame': 'During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks', 'description': 'Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)'}, {'measure': 'Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score', 'timeFrame': 'pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks', 'description': 'Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['People who inject drugs', 'Behavioral Activation', 'Telepsychology', 'Psychosocial Treatment', 'Harm Reduction', 'Low-threshold'], 'conditions': ['Intravenous Drug Usage']}, 'descriptionModule': {'briefSummary': 'The study has two aims: 1) To examine the feasibility and acceptability of administering a telepsychology Behavioral Activation (BA) treatment for substance use among non-treatment-seeking people who inject drugs (PWID); 2) To test the initial efficacy of the treatment from pretreatment to a 1-month follow-up on substance-related problems, readiness to change drug use, and BA. The intervention is hypothesized to be feasible and well-accepted, and within-subject analyses are hypothesized to demonstrate decreases in substance-related problems and increases in readiness to change drug use and BA from pretreatment to a 1-month follow-up.\n\nThe study aims to recruit N=25 non-treatment-seeking PWID from a syringe exchange program (estimated treated sample n=15). Participants will receive 8 sessions of BA over 4 weeks, and assessment of study outcome measures will occur at pretreatment, post-treatment, and a one-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Reports regular recent injection drug use (defined as injecting drugs on at least one day in the last week and injecting drugs for at least two months)\n* Can identify at least one goal or area of change to address during treatment\n* Has regular (at least twice weekly) access to an electronic device that can make phone or video calls and has access to the internet to complete online questionnaires\n\nExclusion Criteria:\n\n* Attending or on a wait list to receive psychosocial substance use treatment\n* \\<5th grade reading level\n* Impairment due to active psychosis\n* Unable to give informed, voluntary, written consent to participate.'}, 'identificationModule': {'nctId': 'NCT04943432', 'briefTitle': 'Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs', 'orgStudyIdInfo': {'id': '19-1458'}, 'secondaryIdInfos': [{'id': '1F31DA049457', 'link': 'https://reporter.nih.gov/quickSearch/1F31DA049457', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'People who inject drugs', 'description': 'People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention', 'interventionNames': ['Behavioral: Behavioral Activation']}], 'interventions': [{'name': 'Behavioral Activation', 'type': 'BEHAVIORAL', 'description': '8 sessions of harm reduction-focused Behavioral Activation for Substance Use', 'armGroupLabels': ['People who inject drugs']}]}, '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': 'Catherine E Paquette, MPS, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': '9 to 36 months following publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill (UNC).', 'accessCriteria': 'The investigator who proposes to use the data has IRB, IEC, or REB and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of North Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}