NCT05187364

BioWare for AUD and PTSD

BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.

Conditions

• PTSD
• Alcohol Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	COPE	The COPE therapy is a talk-therapy in which individuals are asked about their trauma, alcohol use, mood, and behavior. The therapy occurs over 12 sessions and will be paired with a telehealth technology system to determine if it enhances the COPE therapy. The telehealth system is worn on the arm and hand during the out-of-office COPE homework assignments. It consists of a small camera (about the size of a pencil eraser), Bluetooth earpiece with microphone, monitors to measure and record heart rate and skin conductance, and a breathalyzer to assess blood alcohol content. The device will connect to an application on password protected cell phone that will monitor and record the above listed information as well as reported subjective units of distress and craving. A study coach will virtually guide participants through one out-of-office assignment per week using this technology. Interviews and surveys will be collected at study baseline and weekly during treatment.

Timeline

• Start date: 2022-05-05
• Primary completion: 2023-02-20
• Completion: 2023-02-20
• First posted: 2022-01-11
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: United States