Behavioral Activation for Opioid Use Disorder
Primary Purpose
Opioid Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Values-based Behavioral Activation
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring opioid use disorder, behavioral activation, primary care, buprenorphine
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Values-based Behavioral Activation (BA)
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of Recruitment
% of patients approached who consent
Recruitment Pace
Average # of patients enrolled per week
Retention Percent
% of consented patients who complete the study
Treatment Satisfaction
Average satisfaction score
Secondary Outcome Measures
Full Information
NCT ID
NCT05262725
First Posted
February 10, 2022
Last Updated
March 15, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05262725
Brief Title
Behavioral Activation for Opioid Use Disorder
Official Title
A Pilot Study of Behavioral Activation for People With Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
opioid use disorder, behavioral activation, primary care, buprenorphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm, pre/post pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Values-based Behavioral Activation (BA)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Values-based Behavioral Activation
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of Recruitment
Description
% of patients approached who consent
Time Frame
3 months from baseline
Title
Recruitment Pace
Description
Average # of patients enrolled per week
Time Frame
3 months following intervention
Title
Retention Percent
Description
% of consented patients who complete the study
Time Frame
3 months following intervention
Title
Treatment Satisfaction
Description
Average satisfaction score
Time Frame
3 months following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Levy, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Activation for Opioid Use Disorder
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