Behavioral Activation for Opioid Use Disorder

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05262725
Collaborator
(none)
30
1
1
6
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Values-based Behavioral Activation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single-arm, pre/post pilot trialsingle-arm, pre/post pilot trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Behavioral Activation for People With Opioid Use Disorder
Actual Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Values-based Behavioral Activation (BA)

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Recruitment [3 months from baseline]

    % of patients approached who consent

  2. Recruitment Pace [3 months following intervention]

    Average # of patients enrolled per week

  3. Retention Percent [3 months following intervention]

    % of consented patients who complete the study

  4. Treatment Satisfaction [3 months following intervention]

    Average satisfaction score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Robert Levy, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05262725
Other Study ID Numbers:
  • FMCH-2022-30580
First Posted:
Mar 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022