BioWare for AUD and PTSD

Medical University of South Carolina4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PTSD Alcohol Use Disorder

Interventions

COPEBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female; aged 18-70 years. 2. Able to provide written informed consent. 3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder. 4. Meet DSM-5 diagnostic criteria for current PTSD. 5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation. Exclusion Criteria: 1. Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders. 2. Current suicidal or homicidal ideation and intent. 3. Psychotropic medications which have been initiated during the past 4 weeks. 4. Acute alcohol withdrawal. 5. Pregnancy or breastfeeding for people of childbearing potential. 6. Currently enrolled in evidence based behavioral treatment for AUD or PTSD. 7. Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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

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

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

System Usability Scale

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.

Time frame: Week 12

Data from ClinicalTrials.gov

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