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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564663
• Other study ID #: STUDY00006258
• Secondary ID: R01AA028213
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: December 2023
• Source: Michigan State University
• Contact: Lindsey McCracken
• Phone: (734) 560-0661
• Email: mccrac70[@]msu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• PTSD Coach App + Brief Support
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)
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.

Locations

Country	Name	City	State
United States	Pine Rest Christian Mental Health Services	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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