Recruiting

Opioid Use Disorder

Sponsor:

VA Office of Research and Development

Code:

NCT06454903

Conditions

Opioid-Related Disorders

Psychosocial Functioning

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACT to RECOVER

Smartphone-based Symptom-Monitoring

Study Details

Brief summary:

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.

Conditions

Opioid-Related Disorders

Psychosocial Functioning

Quality of Life

Study ID

NCT06454903

Start date

Apr 2, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-For the Phase 3, Stage 1b RCT The investigators will be recruiting Veterans engaged in MOUD who also demonstrate deficits in psychosocial functioning (N = 40, n = 20 per condition).

Eligible Veterans in must have:

  • a current Opioid Use Disorder (OUD) diagnosis
  • active Medication treatment for OUD (MOUD) prescription for buprenorphine or methadone
  • have a Veterans Rand 12 (VR-12) Physical Component Scale (PCS) or Mental Component Scale (MCS) that is <1SD below the normed mean for their respective sex-assigned-at-birth (Selim et al., 2008).

Exclusion Criteria:

Participants may not:

  • have untreated major psychiatric disorders (e.g., psychotic disorders)
  • current (i.e., past-month) suicidal/homicidal ideation with intent (i.e., a positive C-SSRS)
  • cognitive/medical impairments precluding meaningful participation (via clinician determination based on participant's behavior and/or chart review)

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ACT to RECOVER

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

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.

Primary outcome measure

  • Theoretical Framework of Acceptability (TFA) scale [ Time Frame: Phase 3 (Stage 1b RCT): Baseline (week 0); Endpoint (Week 4) ]
  • App usage: Openings [ Time Frame: Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5) ]
  • App usage: Duration [ Time Frame: Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5) ]
  • Enrollment: Enrollment Rate [ Time Frame: End of Month 60 (Final month of project, upon which completion of Phase 3 (Stage 1b RCT) recruitment and follow-up is anticipated to complete) ]
  • App usage: Completion [ Time Frame: Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5) ]
  • Enrollment: Attrition [ Time Frame: End of Month 60 (Final month of project, upon which completion of Phase 3 (Stage 1b RCT) recruitment and follow-up is anticipated to complete) ]
  • Systems Usability Scale (SUS) [ Time Frame: Phase 3 (Stage 1b RCT): Endpoint (Week 4) ]

Central Contacts and Locations

Central contacts

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Principal Investigator:

Noah R Wolkowicz, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Opioid-Related Disorders
  • Psychosocial Functioning
  • Quality of Life
  • Mobile Applications
  • Smartphone Apps
  • Acceptance and Commitment Therapy
  • User-Centered Design

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-17.