Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs

Not Applicable

Completed

• Conditions: Intravenous Drug Usage
• Interventions: Behavioral: Behavioral Activation

• Registration Number: NCT04943432
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

The 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-29
• Study Start: 2021-09-29
• Primary Completion: 2022-05-08
• Study Completion: 2022-05-08
• Status Verified: 2022-08
• Results First Submitted: 2023-03-20
• Results First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Results First Posted: 2023-05-30
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• At least 18 years of age
• 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)
• Can identify at least one goal or area of change to address during treatment
• 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

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Exclusion Criteria

• Attending or on a wait list to receive psychosocial substance use treatment
• <5th grade reading level
• Impairment due to active psychosis
• Unable to give informed, voluntary, written consent to participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People who inject drugs	Behavioral Activation	People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention

Primary Outcome Measures

Name	Time	Method
Treatment Attendance (Feasibility)	During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks	Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score	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	Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)
Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score	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	Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
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)	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	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)
Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)	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	Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)	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	Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview	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	Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)
Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score	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	General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)
Goal Attainment Assessed With Modified Goal Attainment Scale Score	During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks	Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)
Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score	from Pretreatment up to 2 months posttreatment	Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)
Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score	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	Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)
Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score	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	Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score	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	HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States