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OpenTrials
Completed

NCT Number: NCT04943432

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

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.

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Key information

Conditions

Intravenous Drug Usage Behavior Harm Reduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Activation

Behavioral

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

Primary outcomes

  1. Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score

    Time frame: 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).

  2. 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)

    Time frame: 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.

  3. 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)

    Time frame: 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)

  4. Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score

    Time frame: 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)

  5. Treatment Attendance (Feasibility)

    Time frame: 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)

  6. Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)

    Time frame: 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)

  7. Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)

    Time frame: 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)

Secondary outcomes

  1. Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score

    Time frame: 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)

  2. Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score

    Time frame: 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)

  3. Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score

    Time frame: 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)

  4. Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score

    Time frame: 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)

  5. Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview

    Time frame: 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)

  6. Goal Attainment Assessed With Modified Goal Attainment Scale Score

    Time frame: 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)

  7. Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of North Carolina

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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