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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Values-based Behavioral Activation (BA) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Levy, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39439755 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2021 | Dec 12, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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single-arm, pre/post pilot trial
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