BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PTSD
- Sponsor
- Medical University of South Carolina
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Amber Jarnecke
Research Assistant Professor
Medical University of South Carolina
Eligibility Criteria
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.
Outcomes
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.