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

Sponsor

Michigan State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05564663

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

300

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Alcohol Use Disorder	Behavioral: PTSD Coach App + Brief Support Behavioral: Enhanced Usual Care (EUC)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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).
Active Comparator: Enhanced Usual Care (EUC) 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) 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.

Arm

Intervention/Treatment

Experimental: 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.

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).

Active Comparator: Enhanced Usual Care (EUC)

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)

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently in addictions treatment
Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pine Rest Christian Mental Health Services	Grand Rapids	Michigan	United States	49548

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kipling Bohnert, Michigan State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kipling Bohnert, Associate Professor, Michigan State University

ClinicalTrials.gov Identifier:

NCT05564663

Other Study ID Numbers:

STUDY00006258
R01AA028213

First Posted:

Oct 3, 2022

Last Update Posted:

Oct 3, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Alcoholism

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Oct 3, 2022