Substance Use Disorders, Treatment Adherence and Compliance
Conditions
Keywords
mhealth, stress, craving, wearables, technology, digital diagnostics, digital health
Brief summary
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
Detailed description
RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.
Interventions
DEVICERAE
Subjects in the interventional group will have access to the RAE Health mobile app which receives continuous physiologic data from a wearable device. Algorithms embedded in the RAE app detect stress and craving events, and trigger mobile phone notifications when detected. Notifications are paired to real-time mindfulness based interventions.
Sponsors
University of Massachusetts, Worcester
University of Texas at Tyler
ContinueYou, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Enrolled in an outpatient SUD treatment program * Enrolled in treatment for \< 90 days * Fluent in English * Have access to a smartphone with iOS or Android Capabilities * Capable of providing informed consent
Exclusion criteria
* Pregnancy * Prisoner Status * Significant limitation of range of motion of non-dominant arm (amputation or fracture)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with return to drug use | 3 months | Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants retained in treatment | 3 months | Participants status as engaged in recovery treatment (index treatment program or other) |
| Number of hospitalizations and emergency department visits per participant | 3 months | Includes absolute number of Emergency Department visits (SUD and non-SUD related), number of unplanned hospital admissions (SUD and non-SUD related), number of days hospitalized (SUD and non-SUD related admissions) and overdose related visits |
Countries
United States
Outcome results
None listed