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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Posttraumatic Stress Disorder
• Interventions: Behavioral: Enhanced Usual Care (EUC); Behavioral: PTSD Coach App + Brief Support

• Registration Number: NCT05564663
• Lead Sponsor: Michigan State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-03
• Study Start: 2023-10-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care (EUC)	Enhanced Usual Care (EUC)	EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.
PTSD Coach App + Brief Support	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.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5) Change	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	Baseline, 1-, 3-, 6-, and 12-months	The TLFB assessment method will be used to assess alcohol use in the past 30-days.

Trial Locations

Locations (1)

Pine Rest Christian Mental Health Services; 🇺🇸 Grand Rapids, Michigan, United States