Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT06454903
Status
Recruiting
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Conditions

  • Opioid-Related Disorders
  • Psychosocial Functioning
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACT to RECOVER — BEHAVIORAL
    During Phase 3 (Stage 1b RCT), the treatment condition will employ ACT to RECOVER. ACT to RECOVER will be a smartphone app designed to act as a flexible, semi-structured, user-friendly adjunct to standard medication treatment for opioid use disorder. Content will include components appropriate for either self-management and/or use with providers. ACT to RECOVER will be designed to have major ACT-focused modules completable within 1 month.
  • Smartphone-based Symptom-Monitoring — BEHAVIORAL
    During Phase 3 (Stage 1b RCT), the control condition will employ a smartphone-based symptom monitoring program in an effort to provide a balanced alternative to the treatment condition with respect to attention, time using a mobile application, and nonspecific intervention effects. This condition will not, however, include any content or components from the Prototype Digital Intervention hypothesized to produce active clinical effects.

Study Details

Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD. Acceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care. Fortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in "real-world" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD. The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called "ACT to RECOVER" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery). The study will occur in 3 phases: Phase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10). Phase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability. Phase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20). * (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures. * (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.

Key Dates

Start date
Apr 2, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will receive the prototype ACT to RECOVER smartphone intervention for 4 weeks.
  • Sham Comparator: Control
    This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will be assigned to receive a smartphone-based symptom-monitoring program for 4 weeks.

Primary Outcome Measure

Theoretical Framework of Acceptability (TFA) scale [ Time Frame: Phase 3 (Stage 1b RCT): Baseline (week 0); Endpoint (Week 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Noah R Wolkowicz, PhD
[email protected]
203-932-5711
Noah R Wolkowicz, PhD (PRINCIPAL_INVESTIGATOR)

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