Behavioral Activation for Opioid Use Disorder

NCT ID: NCT05262725

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2023-02-23

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.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm, pre/post pilot trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Values-based Behavioral Activation (BA)

Group Type EXPERIMENTAL

Values-based Behavioral Activation

Intervention Type BEHAVIORAL

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.

Interventions

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Values-based Behavioral Activation

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Levy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Hooker SA, Kim H, Lonergan-Cullum M, Busch AM, Nissly T, Levy R. Adapting behavioral activation for patients receiving medications for opioid use disorder in primary care: a pilot study. Front Psychol. 2024 Oct 8;15:1439946. doi: 10.3389/fpsyg.2024.1439946. eCollection 2024.

Reference Type DERIVED
PMID: 39439755 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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FMCH-2022-30580

Identifier Type: -

Identifier Source: org_study_id

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