NCT05262725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 10, 2022

Last Update Submit

March 15, 2023

Conditions

Opioid Use Disorder

Keywords

opioid use disorderbehavioral activationprimary carebuprenorphine

Outcome Measures

Primary Outcomes (4)

  • Feasibility of Recruitment

    % of patients approached who consent

    3 months from baseline

  • Recruitment Pace

    Average # of patients enrolled per week

    3 months following intervention

  • Retention Percent

    % of consented patients who complete the study

    3 months following intervention

  • Treatment Satisfaction

    Average satisfaction score

    3 months following intervention

Study Arms (1)

Values-based Behavioral Activation (BA)

EXPERIMENTAL
Behavioral: Values-based Behavioral Activation

Interventions

Values-based Behavioral ActivationBEHAVIORAL

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.

Values-based Behavioral Activation (BA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

    PMID: 39439755DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Robert Levy, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm, pre/post pilot trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 2, 2022

Study Start

March 30, 2022

Primary Completion

February 23, 2023

Study Completion

February 23, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

US(1)