Behavioral Activation for Opioid Use Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: Values-based Behavioral Activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm, pre/post pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Values-based Behavioral Activation (BA)<br> | Behavioral: Values-based Behavioral Activation<br>* Initially, patients complete a values assessment in which they identify personal values in various life domains. With the assistance of a clinician, patients set incremental behavior goals to move their daily actions to better align with their self-reported values. Goal completion allows the patient to achieve outcomes consistent with recovery, and they potentially experience enjoyment, self-efficacy, and confidence as they progress through the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Recruitment | % of patients approached who consent | 3 months from baseline | 
| Recruitment Pace | Average # of patients enrolled per week | 3 months following intervention | 
| Retention Percent | % of consented patients who complete the study | 3 months following intervention | 
| Treatment Satisfaction | Average satisfaction score | 3 months following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use disorder, behavioral activation, primary care, buprenorphine