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OpenTrials
Active, Not Recruiting

NCT Number: NCT05564663

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Posttraumatic Stress Disorder Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, 49548, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PTSD Coach App + Brief Support

Behavioral

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).

enhanced usual care (EUC)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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