Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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. The investigators 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.

Time frame
Phase 3 (Stage 1b RCT): Baseline (week 0); Endpoint (Week 4)
2

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.

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

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.

Time frame
Phase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)
4

Enrollment: Enrollment Rate

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

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)

Secondary outcomes

1

Usability Survey

The usability survey items are drawn from a questionnaire developed by Wilson and Lankton (2004) to measure a range of health information technology areas. Each item is scored on a 7 point Likert scale where 1 = strongly disagree and 7 = strongly agree. There are 8 subscales: 1. Satisfaction with Medical Care Scale (3 items, range 3 - 21); 2. Health Knowledge Scale (2 items, range 2 to 14); 3. Internet Dependence Scale (4 items, range 4 to 28); 4. Information-seeking Preference Scale (4 items, range 4 to 28); 5. Intrinsic Motivation Scale (3 items, range 3 to 21); 6. Perceived Ease of Use Scale (3 items, range 3 to 21); 7. Perceived Usefulness: Extrinsic Motivation Scale (3 items, range 3 to 21); 8. Behavioral Intention to Use E-health Scale (2 items, range 2 - 14). For each scale, items are summed, with higher score indicating greater levels of satisfaction, knowledge, dependence, information preference, motivation, ease of use, usefulness, and intention to use the system.

Time frame
Phase 3 (Stage 1b RCT): Endpoint (Week 4)
2

Values-based living (VQ)

Valued living will be assessed using the Valuing Questionnaire (VQ), which assesses the extent to which personal values have been enacted within the past week. It is designed to capture the quality of valued action (i.e., the extent to which behaviors accord with what one values) using everyday language and without reference to specific life domains.

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

Multidimensional Experiential Avoidance Questionnaire (MEAQ)

A 62-item self-report measure of experiential avoidance, including subscales on Behavioral Avoidance (11 items, range 11 to 66), Distress Aversion (13 items, range 13 to 78), Procrastination (7 items, range 7 to 42), Distraction \& Suppression (7 items, range 7 to 42), Repression \& Denial (13 items, range 13 to 78), and Distress Endurance (11 items, range 11 to 66). The scale for all items ranges from 1 (strong disagree) to 6 (strongly agree). Greater scores within each subscale indicate greater levels of the named construct. A total score can be obtained with the following calculation: Behavioral Avoidance + Distress Aversion + Procrastination + Distraction \& Suppression + Repression \& Denial + (77 - Distress Endurance).

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

Veteran's RAND 36 (VR-36)

Quality of Life will be assessed using the Veteran's RAND 36-item Health Survey (VR-36), which is designed to assess health-related quality of life with respect to role limitations, social and physical functioning, general and mental health, energy and fatigue, and bodily pain. It is often summarized into physical and mental functioning components, and is one of the most widely utilized and valid measures of physical and psychological well-being.

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

Other outcomes

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