A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

Conditions

• Dependence, Opioid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brief, values based intervention for early buprenorphine treatment — BEHAVIORAL
  The initial intervention structure consists of four weekly sessions. Session one focuses on values clarification using an empirically validated clinical exercise. The second session will include a discussion of the connection between values, addiction treatment engagement, and the challenges associated with discomfort (i.e., withdrawal and cravings) in early treatment. The third session will focus on barriers and goal setting to enhance self-efficacy for committed action. The final session will review progress made and focus on the Veterans' recovery plan moving forward. The initial study intervention will be refined iteratively using Phase 1 stakeholder and Phase 2 open trial participant feedback.
• Treatment as Usual — BEHAVIORAL
  Veterans will be recruited from an intensive treatment phase where all Veterans receive case management and regular group therapy in addition to appointments with their buprenorphine, methadone, or naltrexone prescriber. After the first two weeks, they have the option to continue with a less intensive group schedule and case management support through an Aftercare program.

Study Details

The US Veteran community continues to feel the impact of the overdose crisis, and opioid use disorder (OUD) diagnoses among Veterans continue to rise. Medication treatment (e.g., buprenorphine, methadone, naltrexone) helps prevent relapse and reduce overdose risk, but does not help with the psychological, social, and functional challenges of early recovery. Therapies that focus on interpersonal functioning and community integration may help improve quality of life during this high-risk period. This research project will create and test a brief, values-based treatment to help Veterans improve their interpersonal functioning and community integration during early treatment. This study will have three phases. Phase 1 will involve the development of the treatment and adaptation using interviews with Veterans and VA Providers. Phase 2 will test the treatment with a group of 10 Veterans to make sure the treatment can be delivered as intended, and to make changes to the treatment or study procedures based on Veteran feedback. Finally, Phase 3 will test the treatment compared to usual treatment in a pilot randomized controlled trial with a group of 40 Veterans. This final phase will provide additional information about Veterans' experience of the treatment and study procedures and the preliminary effects of the treatment on quality of life and related outcomes.

Key Dates

Start date

Sep 1, 2023

Status verified

Jul 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Open Pilot
  In Phase 2, all Veterans will receive the active treatment.
• Experimental: Active Condition
  In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to the active treatment.
• Active Comparator: Treatment as Usual
  In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to treatment as usual.

Primary Outcome Measure

Expectancy item of the Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: 1 week ]

Central Contacts

• Victoria Ameral, PhD
  (781) 687-3015
  [email protected]
• Anne Marie Hernon
  (781) 687-2903
  [email protected]

Locations (1)

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