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Completed

NCT Number: NCT05262725

Behavioral Activation for Opioid Use Disorder

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Values-based Behavioral Activation

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.

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: 3 months from baseline

    % of patients approached who consent

  2. Recruitment Pace

    Time frame: 3 months following intervention

    Average # of patients enrolled per week

  3. Retention Percent

    Time frame: 3 months following intervention

    % of consented patients who complete the study

  4. Treatment Satisfaction

    Time frame: 3 months following intervention

    Average satisfaction score

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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