Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Michigan State University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- PTSD Checklist for DSM-5 (PCL-5) Change
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
PTSD Coach App + Brief Support
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.
Intervention: PTSD Coach App + Brief Support (Behavioral)
Enhanced Usual Care (EUC)
EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.
Intervention: Enhanced Usual Care (EUC) (Behavioral)
Outcomes
Primary Outcomes
PTSD Checklist for DSM-5 (PCL-5) Change
Time Frame: Baseline, 1-, 3-, 6-, and 12-months
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.
Timeline Followback (TLFB) for Alcohol Change
Time Frame: Baseline, 1-, 3-, 6-, and 12-months
The TLFB assessment method will be used to assess alcohol use in the past 30-days.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kipling Bohnert
Associate Professor
Michigan State University