Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
Recruiting
N/AInterventional Study
Opioid-Related DisordersPsychosocial FunctioningQuality of Life
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans with Opioid Use Disorder who also have challenges in their daily functioning. Participants will help test a new smartphone app designed to support their treatment and overall quality of life.
Are You a Good Fit for This Trial?
Must be takingBuprenorphineMethadone
You may be able to join if
I have been diagnosed with Opioid Use Disorder.
I am currently receiving medication treatment for Opioid Use Disorder.
I have a score on the VR-12 Physical Component Scale or Mental Component Scale that is below average for my sex.
You may not be able to join if
I have untreated major psychiatric disorders.
I have had thoughts of suicide or homicide in the past month.
I have cognitive or medical impairments that prevent me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 fu…
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.
Trial Locations
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Eligibility Criteria
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 Medic…
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)
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