mHealth, Opioid Use Disorder, Peer Support
Conditions
Keywords
Peer Recovery Support, Digital Support
Brief summary
Many patients stop medication-based treatments for Opioid Use Disorder (OUD) prematurely, placing them at increased risk for overdose and death. Providing targeted interventions for OUD, particularly through an accessible, digital health platform, is a potential way to enhance recovery and keep patients engaged in care. The current study seeks to test whether a digital mental health platform, delivered by peer recovery support specialists to individuals prescribed buprenorphine or methadone medication, will improve treatment outcomes for this high risk population.
Interventions
BEHAVIORALVira Platform
The Vira Platform is a digitally enhanced mental health care platform consisting of a patient smartphone application that utilizes mobile sensing to garner insight about patterns of behavior related to negative affect, sleep, and anhedonia while simultaneously providing just-in-time nudges to increase positive interactions with the environment. Behavioral activation is the primary intervention being deployed through the Vira App. It is accompanied by a practitioner platform that is delivered through certified peer recovery support specialist to encourage engagement with the app and promote social support.
BEHAVIORALTreatment-As-Usual
The treatment-as-usual condition consists of standard outpatient buprenorphine or methadone treatment. These medications are among those considered to be the gold standard of care for treating opioid use disorder, and therefore, represents an adequate control intervention for this study.
Sponsors
Rhode Island Hospital
Ksana Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 22+ * Current Opioid Use Disorder diagnosis * Prescribed buprenorphine or methadone * Initiated or reinitiated buprenorphine or methadone treatment recently * Access to personal smartphone
Exclusion criteria
* Not fluent in English * Limited mental capacity or inability to provided informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication for Opioid Use Disorder Retention | Baseline & 3-Month Follow-up | Retention on buprenorphine or methadone treatment will be verified through medical record chart review. |
| Substance Use Disorder Treatment Engagement | Baseline & 3-Month Follow-up | Addiction treatment records as assessed through medical records will be assessed for participation in addiction treatment services (e.g., 'detox', inpatient services, outpatient therapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use assessed with the Timeline Follow-back | Baseline & 3-Month Follow-up | Self-reported opioid use will be assessed with a Timeline Follow-back interview and biochemically confirmed with Urine Drug Screens. The timeline follow-back is an established semi-structured interview format used to cue accurate recall about substance use. Opioid use will be operationalized as the percentage of days of opioid use in between assessments. |
| Opioid Craving measured with the Opioid Craving Scale | Baseline & 3-Month Follow-up | The Opioid Craving Scale will be used to assess opioid craving. This assessment has been used extensively in assessments of opioid recovery demonstrating internal consistency, reliability, and concurrent and predictive validity. Scores range from 0 to 10, with higher scores representing greater opioid craving. |
| Anhedonia assessed with the Snaith-Hamilton Pleasure Scale | Baseline & 3-Month Follow-up | The degree to which participants experience anhedonic symptoms will be measured with the Snaith-Hamilton Pleasure Scale. This questionnaire is a psychometrically sound assessment of anhedonia. Higher scores represent greater anhedonia. |
| Sleep Deficiency assessed with the Insomnia Severity Index (ISI) | Baseline & 3-Month Follow-up | Sleep deficiency will be assessed with the Insomnia Severity Index (ISI), a widely used questionnaire with strong internal consistency, reliability, and convergent validity. Higher scores represent greater sleep deficiency. |
| Negative Affect assessed with the Positive Affect and Negative Affect Schedule-Expanded Form | Baseline & 3-Month Follow-up | The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS-X) will be utilized to assess negative affect. The PANAS-X is a popular assessment of negative affect and boasts strong psychometric properties. Higher scores represent greater negative affect. |
| Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | Baseline & 3-Month Follow-up | Perceived quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. This 16-item questionnaire has shown internal consistency, test-retest reliability, and convergent and criterion validity. Higher scores represent greater perceived quality of life. |
| Wellbeing measured by the World Health Organization-Five Well-Being Index | Baseline & 3-Month Follow-up | Wellbeing will be assessed by the World Health Organization-Five Well-Being Index, a widely used 5-item questionnaire. Higher scores represent greater wellbeing. |
| Perceived Social Support assessed with the Multidimensional Scale of Perceived Social Support | Baseline & 3-Month Follow-up | Social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS), a psychometrically sound assessment that has demonstrated adequate reliability and validity, including robust factorial validity, and measures perceived social support from different sources. Higher scores represent greater perceived social support. |
| Participant Safety | Baseline & 3-Month Follow-up | All adverse events during the course of the study will be documented. Participant safety will be comprised of the frequency of adverse events. |
Countries
United States
Contacts
CONTACTSusan Ramsey, PhD
CONTACTEvan Ames
PRINCIPAL_INVESTIGATORSusan Ramsey, PhD
Rhode Island Hospital
Outcome results
None listed