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Clinical Trials/NCT05262725
NCT05262725
Completed
N/A

A Pilot Study of Behavioral Activation for People With Opioid Use Disorder

University of Minnesota1 site in 1 country21 target enrollmentMarch 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
University of Minnesota
Enrollment
21
Locations
1
Primary Endpoint
Retention Percent
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2022
End Date
February 23, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Retention Percent

Time Frame: 3 months following intervention

% of consented patients who complete the study

Recruitment Pace

Time Frame: 3 months following intervention

Average # of patients enrolled per week

Treatment Satisfaction

Time Frame: 3 months following intervention

Average satisfaction score

Feasibility of Recruitment

Time Frame: 3 months from baseline

% of patients approached who consent

Study Sites (1)

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