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

NCT04943432 | Completed Results

• 2 other identifiers: 19-14581F31DA049457
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Drug Usage

Keywords

People who inject drugs; Behavioral Activation; Telepsychology; Psychosocial Treatment; Harm Reduction; Low-threshold

Outcome Measures

Primary Outcomes (7)

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

  Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).

  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

• 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)

  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.

  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

• 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)

  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)

  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

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

  Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)

  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

• Treatment Attendance (Feasibility)

  Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)

  During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks

• Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)

  Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)

  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

• Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)

  Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)

  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

Secondary Outcomes (7)

• 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

• 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

• 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

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

  from Pretreatment up to 2 months posttreatment

• 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

Study Arms (1)

People who inject drugs

EXPERIMENTAL

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

Behavioral: Behavioral Activation

Interventions

Behavioral Activation BEHAVIORAL

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

People who inject drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of North Carolina: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Catherine Paquette, MA, MPS
• Organization: University of North Carolina at Chapel Hill

cpaq@live.unc.edu

919-962-5082

Study Officials

• Catherine E Paquette, MPS, MA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 29, 2021
• Study Start: September 29, 2021
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: May 30, 2023
• Results First Posted: May 30, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)