BioWare for AUD and PTSD
Primary Purpose
PTSD, Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPE
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPE Therapy Arm
Arm Description
Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)
Outcomes
Primary Outcome Measures
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
Mean score of System Usability Scale
Acceptability is mean score of 68 or greater on System Usability Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05187364
First Posted
December 28, 2021
Last Updated
April 17, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05187364
Brief Title
BioWare for AUD and PTSD
Official Title
BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPE Therapy Arm
Arm Type
Experimental
Arm Description
Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)
Intervention Type
Behavioral
Intervention Name(s)
COPE
Intervention Description
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 Outcome Measure Information:
Title
Percentage of participants who turn on and off equipment in 5 minutes or less
Description
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)
Title
Mean score of System Usability Scale
Description
Acceptability is mean score of 68 or greater on System Usability Scale
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber M Jarnecke, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BioWare for AUD and PTSD
We'll reach out to this number within 24 hrs