Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment

NCT06454903 | Recruiting

• 2 other identifiers: D5015-WIK2RX005015-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Theoretical Framework of Acceptability (TFA) scale

  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. We will use the prospective scale (i.e., assessing how acceptable participants think the ACT to RECOVER app would be if they were to use as part of their treatment). The TFA's scale asks participants to rate 7 dimensions of acceptability (affective attitude towards a health intervention, burden, value alignment, understanding of intervention functioning, perceived benefit, perceived effectiveness, and self-efficacy) on a 5-point scale, with avg.'s \>3 indicating minimum degrees of acceptability.

  Phase 3 (Stage 1b RCT): Baseline (week 0); Endpoint (Week 4)

• App usage: Openings

  Continuously-recorded via smartphone apps in respective conditions as a frequency count of the number of times a respective app is opened.

  Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)

• App usage: Duration

  Continuously-recorded via smartphone apps in respective conditions as the total duration of time (as number of minutes) spent using the respective app.

  Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)

• Enrollment: Enrollment Rate

  Participant enrollment rate. Study target is \>2 participants/month on avg., assessed upon completion of Stage 3 study procedures.

  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

  Continuously-recorded via smartphone apps in respective conditions as the number of module/symptom reports completed. Targets are for an avg. of \>3/6 ACT to RECOVER modules + 1 General module completed (ACT to RECOVER condition) or an avg. of \>15/30 days of symptom monitoring reports (symptom monitoring control condition).

  Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)

• Enrollment: Attrition

  Percentage of participant attrition. Study target is \<35.5% per study arm, assessed upon completion of Stage 3 study procedures.

  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)

  The SUS is a 10-item measure, scored on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5), that assesses human-computer interaction. The SUS generates a subjective evaluation score using a globally accepted scale and to understand if the system in its current form is sufficiently usable. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of system usability. SUS scores have a range of 0 to 100, with higher scores suggesting greater system usability. A SUS score above 68 (study target) is regarded as above average, and a SUS score above 80 is regarded as high and a score above which participants are likely to recommend the product to friends.

  Phase 3 (Stage 1b RCT): Endpoint (Week 4)

Secondary Outcomes (16)

• Usability Survey

  Phase 3 (Stage 1b RCT): Endpoint (Week 4)

• Values-based living (VQ)

  Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5)

• Multidimensional Experiential Avoidance Questionnaire (MEAQ

  Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5)

• Veteran's RAND 36 (VR-36)

  Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5)

• Timeline Follow Back for Illicit Opioid Use and Medication Compliance

  Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5)

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: ACT to RECOVER

Control

SHAM COMPARATOR

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.

Behavioral: Smartphone-based Symptom-Monitoring

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.

Also known as: Treatment

Treatment

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.

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Phase 3, Stage 1b RCT we will be recruiting Veterans enrolled within the VA CT Healthcare System with:
• Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes
• Active Medication treatment for OUD prescription for buprenorphine or methadone (in any formulation)
• A working smartphone with wireless capabilities (to allow for download of ACT to RECOVER) or is willing to use a study-provided smartphone
• Competency to provide written informed consent
• years of age or older

You may not qualify if:

• Participants may not:
• Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit
• Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)
• Be expressing current, active suicidal/homicidal ideation (i.e., current intent to harm themselves or someone else)
• Have any cognitive/medical impairment precluding study participation or use of smartphones/smartphone applications.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Noah R Wolkowicz, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah R Wolkowicz, PhD

CONTACT

(203) 932-5711; Noah.Wolkowicz@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study investigators will not inform outcome assessors during Stage 3 (Phase 1b clinical trial) of participant condition assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Stages 1 of this project will focus on developing content for a smartphone intervention (ACT to RECOVER) with input from stakeholders; Stage 2 will conduct iterative usability assessment of a beta version of ACT to RECOVER to via iterative small waves of field-testing to assess content acceptability and system usability; Stage 3 will conduct a Phase 1b randomized clinical trial, examining the acceptability and feasibility of comparing ACT to RECOVER to a smartphone-based symptom monitoring control group. Outcomes within Stage 3 will include treatment acceptability, procedural feasibility, and assessment of changes in psychosocial functioning and symptoms of opioid use disorder.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 12, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)