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RAE (Realize, Analyze, Engage)

NCT05227339 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2024-07-25

No results posted yet for this study

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

Conditions

Interventions

DEVICE

RAE

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 & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER

  • University of Texas at Tyler

    collaborator OTHER

  • ContinueYou, LLC

    lead INDUSTRY

Principal Investigators

  • Megan Reinhardt · ContinueYou, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2024-02-01
Completion
2024-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227339 on ClinicalTrials.gov