Behavioral Activation for Opioid Use Disorder

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Behavioral: Values-based Behavioral Activation

• Registration Number: NCT05262725
• Lead Sponsor: University of Minnesota

Brief Summary

The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Researcher will evaluate the following aims: 1) examine the feasibility of BA for OUD in primary care, 2) examine whether the BA intervention and study requirements are acceptable to participants, and 3) determine the psychometric properties of the outcome measures in people with OUD. Participants will complete 4-6 brief counseling sessions over the course of 12 weeks. During the first session, participants will discuss values and recovery outcomes important to them. Next, they will set 2-3 personal goals to work on before the next BA session. At the follow-up sessions, participants will update the counselor on progress made or challenges experienced. Personal values will be reviewed and participant goals updated. Study measures (surveys and urine drug tests) will be completed at the start, partway through, and at the end of the intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-02
• Study Start: 2022-03-30
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• At least 18 years of age.
• Diagnosis of opioid use disorder.
• Have an active prescription for buprenorphine-naloxone (Suboxone) for at least one month.
• Patient at Broadway Family Medicine (BFM)

Exclusion Criteria

• Concurrent individual psychotherapy with a psychologist or counselor at least monthly
• Active suicidal ideation (intention, plan, or attempt in the past 30 days, as determined by chart review)
• Dementia, developmental disabilities, or cognitive functioning that is too low to participate in therapy, as determined by chart review

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Values-based Behavioral Activation (BA)	Values-based Behavioral Activation	-

Primary Outcome Measures

Name	Time	Method
Retention Percent	3 months following intervention	% of consented patients who complete the study
Feasibility of Recruitment	3 months from baseline	% of patients approached who consent
Recruitment Pace	3 months following intervention	Average # of patients enrolled per week
Treatment Satisfaction	3 months following intervention	Average satisfaction score

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States