N/A
Completed N=23
Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
Intravenous Drug Usage
Source: ClinicalTrials.gov NCT04943432 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score — 77.00; 86.75; 69.67 score on a scale — p=0.06
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score |
77.00; 86.75; 69.67 | 0.06 |
| PRIMARY 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) |
28.82; 30.25; 29.17 | — |
| PRIMARY 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) |
26.28; 32.62; 29.91 | .01 sig |
| PRIMARY Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score |
22.92; 22.08; 33.34 | .44 |
| PRIMARY Treatment Attendance (Feasibility) |
4.5; 5.5 | — |
| PRIMARY Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability) |
28.9 | — |
| PRIMARY Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability) |
4.5 | — |
| SECONDARY Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score |
14.17; 11.73; 15.14 | .01 sig |
| SECONDARY Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score |
10.14; 11.31; 11.22 | .82 |
| SECONDARY Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score |
16.61; 13.25; 8.00 | .34 |
| SECONDARY Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score |
— | — |
| SECONDARY Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview |
95.46; 85.28; 85.13 | .14 |
| SECONDARY Goal Attainment Assessed With Modified Goal Attainment Scale Score |
— | — |
| SECONDARY Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score |
22.50; 28.0; 22.80 | <.001 sig |
Eligibility Criteria
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
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.
Data sourced from ClinicalTrials.gov (NCT04943432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.