BioWare for AUD and PTSD

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05187364

Collaborator

(none)

Enrollment

Location

Arm

7.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD Alcohol Use Disorder	Behavioral: COPE	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of participants who turn on and off equipment in 5 minutes or less [In-Session Visit (approximately 1 week from baseline)]
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
Mean score of System Usability Scale [Week 12]
Acceptability is mean score of 68 or greater on System Usability Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amber Jarnecke, Research Assistant Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05187364

Other Study ID Numbers:

00115253

First Posted:

Jan 11, 2022

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcoholism

Alcohol Drinking

Study Results

No Results Posted as of May 6, 2022