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

NCT ID: NCT05564663

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PTSD Coach App + Brief Support

Intervention Type 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)

EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kipling Bohnert

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kipling Bohnert

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lindsey McCracken

Role: CONTACT

(734) 560-0661

Melanie Adkins

Role: CONTACT

(517) 353-8623 ext. 42098

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

LeAnn Smart

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AA028213

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006258

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.