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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-05-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Change the Cycle: An RCT to Prevent Injection Initiation

NCT02774954

Substance Abuse, Intravenous HIV Heroin Dependence +3 more

COMPLETED NA

Depression Treatment for Low Income Substance Users

NCT01189552

Substance Use Disorder

COMPLETED NA

Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial

NCT01003496

Drug Addiction

COMPLETED PHASE3

Telehealth-Clinical Advocacy Project

NCT04911426

Substance Use

COMPLETED NA

Behavioral Depression Treatment for African American HIV-infected Substance Users

NCT01351454

Depression Substance Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intravenous Drug Usage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

People who inject drugs

People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention

Group Type EXPERIMENTAL

Behavioral Activation

Intervention Type BEHAVIORAL

8 sessions of harm reduction-focused Behavioral Activation for Substance Use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Activation

8 sessions of harm reduction-focused Behavioral Activation for Substance Use

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No