BioWare for AUD and PTSD

Study Overview
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Brief Summary
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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.

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

Conditions
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PTSD, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: COPE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPE Therapy Arm<br>Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) | Behavioral: COPE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | In-Session Visit (approximately 1 week from baseline) | 
| Mean score of System Usability Scale | Acceptability is mean score of 68 or greater on System Usability Scale | Week 12 |