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NCT06454903 · ClinicalTrials.gov registry record · NA
Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
A NA study of Quality of Life and Opioid-Related Disorders, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06454903: Recruiting NA study of Quality of Life and Opioid-Related Disorders, sponsored by VA Office of Research and Development.
NCT06454903 is a NA study of Quality of Life and Opioid-Related Disorders that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 75 participants, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06454903, a NA study of Quality of Life and Opioid-Related Disorders, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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 usa
Primary Outcome
The Theoretical Framework of Acceptability provides a rigorous framework for assessing the acceptability of health information technology, offering both prospective and retrospective acceptability scales, which respectively assess how acceptable one believes they will find a health intervention and how acceptable they found the intervention after use. The investigators will use the prospective scale (i.e., assessing how acceptable participants think the ACT to RECOVER app would be if they were t
Conditions Studied
Interventions
- BEHAVIORAL ACT to RECOVER
- BEHAVIORAL Smartphone-based Symptom-Monitoring
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-04-02 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
What NCT06454903 shows while recruiting
NCT06454903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Quality of Life appearing as the primary indexed condition, and to 2 interventions - of which ACT to RECOVER is the first listed.
NCT06454903 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06454903 about?
NCT06454903 is a clinical study titled "Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment". 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, metha...
What is the current status of trial NCT06454903?
This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2025-04-02. Estimated completion is 2029-09-30.
What conditions does trial NCT06454903 study?
This clinical trial studies the following conditions: Quality of Life, Opioid-Related Disorders, Psychosocial Functioning.
What interventions are being tested in trial NCT06454903?
The interventions under investigation include: ACT to RECOVER (BEHAVIORAL), Smartphone-based Symptom-Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT06454903?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06454903 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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75 58th of 107 higher than 49 of 107 other Quality of Life trials
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