Clinical trial NCT04943432: Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
Official title: Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Drug Usage
Keywords: People who inject drugs
Behavioral Activation
Telepsychology
Psychosocial Treatment
Harm Reduction
Low-threshold
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of North Carolina
First posted: 2021-06-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
timeFrame: 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
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
timeFrame: 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
measure: Treatment Attendance (Feasibility)
timeFrame: During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks
measure: Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)
timeFrame: 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
measure: Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)
timeFrame: 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:
measure: Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
timeFrame: 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
measure: Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score
timeFrame: 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
measure: Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score
timeFrame: 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
measure: Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score
timeFrame: from Pretreatment up to 2 months posttreatment
measure: Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
timeFrame: 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
measure: Goal Attainment Assessed With Modified Goal Attainment Scale Score
timeFrame: During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks
measure: Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score
timeFrame: 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
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Catherine E Paquette, MPS, MA
role: PRINCIPAL_INVESTIGATOR
References: