Quality of Life Clinical Trial
Official title:
Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder
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.
Status | Not yet recruiting |
Enrollment | 65 |
Est. completion date | May 31, 2029 |
Est. primary completion date | May 30, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 - 18 years of age or older Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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. | Phase 3 (Stage 1b RCT): Endpoint (Week 4) | |
Secondary | 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. | Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | 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). | Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | 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. | Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Timeline Follow Back for Illicit Opioid Use and Medication Compliance | Illicit opioid use and compliance with medication treatment regiments for opioid use disorder will be assessed using Timeline Followback procedures (TLFB) outlined by McCann et al. (2024) for opioid use disorder. These assessments will produce a count of days of illicit opioid and MOUD use during the past month (at baseline) and since the prior assessment timepoint (at midpoint, endpoint, and 5-week follow-up). | Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Short Inventory of Problems - Revised (SIP-R) | The SIP-R will provide a self-report assessment of the adverse consequences of substance use. The SIP-R asks participants to indicate the frequency of 17 different substance-related consequences, which are scored from 0-3. Item responses are then summed to produce a total score, as well as five subscales (physical, social, intrapersonal, interpersonal, and impulse control). Higher scores are indicative of greater substance-related problems and poorer treatment engagement (Kiluk et al., 2013). | Phase 3 (Stage 1b RCT): Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Usability Survey: Perceived Usefulness: Extrinsic Motivation Scale | The Perceived Usefulness: Extrinsic Motivation Scale consists of 3 items drawn from Wilson and Lankton (2004) Usability Survey. Each item is scored on a 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Scale items are summed, with higher score indicating greater belief that using and interacting with a given health intervention will be beneficial to one's healthcare. | Phase 3 (Stage 1b RCT): Endpoint (Week 4) | |
Secondary | Usability Survey: Behavioral Intention to Use E-health Scale | The Behavioral Intention to Use E-health Scale consists of 2 items drawn from Wilson and Lankton (2004) Usability Survey. Each item is scored on a 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Scale items are summed, with higher score indicating greater intent to use a given health intervention. | Phase 3 (Stage 1b RCT): Endpoint (Week 4) | |
Secondary | Values-based living (VQ): Values Progress | Progress towards one's values will be assessed using the Valuing Questionnaire's (VQ's) Values Progress subscale, 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; e.g., "I made progress in the areas of my life I care most about") and contains items 3, 4, 5, 7, and 9 from the VQ. Subscale items are scored on a 0-6 Likert scale (0 = Not at all true, 6 = Completely true) and are summed with higher scores indicating greater values progress. | Stage 3 Phase 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Values-based living (VQ): Values Obstruction | Obstruction of values will be assessed using the Valuing Questionnaire's (VQ's) Values Obstruction subscale, which assesses the extent to which one feels they have been prevented from acting in-concert with personal values within the past week (e.g., "Difficult thoughts, feelings, or memories got in the way of what I really wanted to do") and contains items 1, 2, 6, 8, and 10 from the VQ. Subscale items are scored on a 0-6 Likert scale (0 = Not at all true, 6 = Completely true) and are summed with higher scores indicating greater values obstruction. | Stage 3 Phase 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | 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). | Stage 3 Phase 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Veteran's RAND 36 (VR-36): Physical Component Score | 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. Computer-based algorithms can be used to calculate physical and mental functioning component scores. The Physical Component Score (PCS) provides a greater emphasis on questions of general health, physical functioning, role enactment, and bodily pain. | Phase 3 Stage 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Veteran's RAND 36 (VR-36): Mental Health Component Score | 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. Computer-based algorithms can be used to calculate physical and mental functioning component scores. The Mental health Component Score (PCS) provides a greater emphasis on questions of emotional well-being, mental health and perceptions of vitality, and social functioning. | Phase 3 Stage 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Timeline Follow Back: Illicit Opioid Use | Illicit opioid use opioid use will be assessed using Timeline Followback procedures (TLFB) outlined by McCann et al. (2024) for opioid use disorder. These assessments will produce a count of days of illicit opioid use during the past month (at baseline) and since the prior assessment timepoint (at midpoint, endpoint, and 5-week follow-up). | Phase 3 Stage 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Timeline Follow Back: Medication Compliance | Compliance with medication treatment regiments for opioid use disorder will be assessed using Timeline Followback procedures (TLFB) outlined by McCann et al. (2024) for opioid use disorder. These assessments will produce a count of days of MOUD use during the past month (at baseline) and since the prior assessment timepoint (at midpoint, endpoint, and 5-week follow-up). | Phase 3 Stage 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) | |
Secondary | Short Inventory of Problems - Revised (SIP-R) | : The SIP-R will provide a self-report assessment of the adverse consequences of substance use. The SIP-R asks participants to indicate the frequency of 17 different substance-related consequences, which are scored from 0-3. Item responses are then summed to produce a total score, as well as five subscales (physical, social, intrapersonal, interpersonal, and impulse control). Higher scores are indicative of greater substance-related problems and poorer treatment engagement (Kiluk et al., 2013). | Stage 3 Phase 1b RCT: Baseline (Week 0); Midpoint (Week 2); Endpoint (Week 4); Follow-up (Week 5) |
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