Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.

Official Title
-----------------
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

Conditions
-----------------
Posttraumatic Stress Disorder, Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: PTSD Coach App + Brief Support
* Behavioral: Enhanced Usual Care (EUC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old Currently in addictions treatment Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis A score of 33 or greater on the PTSD Checklist (PCL-5) Own a smart phone or other type of Wi-Fi-enabled device with App capabilities Exclusion Criteria: Injection drug use in the past year Patients who are unable to speak and/or understand English Patients who are currently engaged in specific therapy for PTSD (Prolonged Exposure Therapy, Cognitive Reprocessing Therapy, EMDR)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTSD Coach App + Brief Support<br>PTSD Coach App + Brief Support will include brief instruction and support for the use of the PTSD Coach App developed by the study team. The PTSD Coach App incorporates evidence-based assessment, psychoeducation, and self-management strategies for PTSD symptoms that are customizable to the user. | Behavioral: PTSD Coach App + Brief Support<br>* PTSD Coach App + Brief Support will include downloading the PTSD Coach App for personal use and four, brief (<20 minutes), weekly, individual support sessions. The sessions will focus on the instruction and encouragement of App use and activities (i.e., assessments, self-management strategies, and psychoeducational readings).<br>|
| Active Comparator: Enhanced Usual Care (EUC)<br>EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment. | Behavioral: Enhanced Usual Care (EUC)<br>* EUC will consist of one brief session (with brochure) of PTSD and AUD psychoeducation and referral information for mental health clinics that provide PTSD services, with encouragement to schedule an appointment at one of the listed clinics to discuss PTSD-related symptoms.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for DSM-5 (PCL-5) Change | The PCL-5 is a 20-item, self-reported measure that assesses the 20 DSM-5 symptoms of PTSD. Each symptom is measured on a 0-4 scale, with higher values indicating greater severity. Total scale scores range from 0 to 80. | Baseline, 1-, 3-, 6-, and 12-months | 
| Timeline Followback (TLFB) for Alcohol Change | The TLFB assessment method will be used to assess alcohol use in the past 30-days. | Baseline, 1-, 3-, 6-, and 12-months |