Behavioral Activation for Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262725
• Other study ID #: FMCH-2022-30580
• Status: Completed
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: February 23, 2023

Study information

• Verified date: March 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment	% of patients approached who consent	3 months from baseline
Primary	Recruitment Pace	Average # of patients enrolled per week	3 months following intervention
Primary	Retention Percent	% of consented patients who complete the study	3 months following intervention
Primary	Treatment Satisfaction	Average satisfaction score	3 months following intervention