BioWare for AUD and PTSD

September 18, 2024 updated by: Amber Jarnecke, Medical University of South Carolina

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COPE Therapy Arm
Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
In-Session Visit (approximately 1 week from baseline)
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Amber M Jarnecke, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00115253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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