BioWare for AUD and PTSD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PTSD Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female; aged 18-70 years.
Able to provide written informed consent.
Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
Meet DSM-5 diagnostic criteria for current PTSD.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion criteria

Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
Current suicidal or homicidal ideation and intent.
Psychotropic medications which have been initiated during the past 4 weeks.
Acute alcohol withdrawal.
Pregnancy or breastfeeding for people of childbearing potential.
Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.

Treatment and study plan

COPE

Behavioral

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.

Primary outcomes

Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less

Time frame: In-Session Visit (approximately 1 week from baseline)

Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
System Usability Scale

Time frame: Week 12

The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 11, 2022
Registry last updated: Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed