NCT05564663

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Oct 2023May 2026

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

September 28, 2022

Last Update Submit

May 5, 2025

Conditions

Posttraumatic Stress DisorderAlcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

PTSD Coach App + Brief Support

EXPERIMENTAL

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

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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)

Interventions

PTSD Coach App + Brief SupportBEHAVIORAL

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).

PTSD Coach App + Brief Support
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.

Enhanced Usual Care (EUC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, 49548, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Kipling Bohnert

    Michigan State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey McCracken

CONTACT

(734) 560-0661mccrac70@msu.edu

Melanie Adkins

CONTACT

(517) 353-8623madkins@msu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

October 6, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)