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Not yet recruitingNCT07903974Updated Oct 29, 2026

Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use

An interventional study of Written Exposure Therapy (WET) and Clinician Supported PTSD Coach App (CS-PTSD) in Post Traumatic Stress Disorder PTSD and Hazardous Alcohol Use, sponsored by University of Michigan. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This project will test the effectiveness of a stepped-care talk therapy model for patients with PTSD and Hazardous Alcohol use (HAU). Specifically, the researchers are testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after five sessions is more helpful than staying with the same therapy, depending on how well it is working.

Read the detailed description

In the case of uneven dropout across interventions, the research team will recruit additional patients until target sample is reached.

02

Conditions studied

  • Post Traumatic Stress Disorder PTSD
  • Hazardous Alcohol Use

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Keywords

  • stepped care models
  • federally qualified health centers
03

In context

Combat Disorders

147 studies on the registry are indexed under Combat Disorders; 76 are open to participants now.

This study's planned enrollment of 12 is below the median of 71 across 124 interventional studies indexed under Combat Disorders.

Browse Combat Disorders studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,505 studies on the registry; 191 are open to participants now.

Of its 168 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patients will be eligible for the study if they:

  1. are age 18 years or older
  2. receive care at a participating Federally Qualified Health Center (FQHC)
  3. have a PTSD checklist (PCL)-5 score ≥28
  4. show probable HAU as measured by the Alcohol Use Disorders Identification Test (AUDIT) (score of 8-25 for men, 6-25 for women with past-month alcohol use)
  5. have had psychotropic medication stability for at least 4 weeks
  6. speak English

Patients will be eligible for the qualitative portion of the study if they:

  1. Enrolled into the randomized controlled trial (RCT) AND
  2. Were a treatment responder OR
  3. Were a treatment non-responder

Patients will be excluded if they have:

  1. severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
  2. high risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: see section 7.8. Suicide Risk Protocol)
  3. active psychosis or unmanaged bipolar disorder

6) current engagement in a trauma- or alcohol-focused treatment 7) Patients who do not speak English will be excluded for logistical reasons

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Written Exposure Therapy (WET) then Phone follow up

    Behavioral: Written Exposure Therapy (WET) · Behavioral: Phone follow up

  • Experimental
    Written Exposure Therapy (WET) then continue with WET

    Behavioral: Written Exposure Therapy (WET)

  • Experimental
    Written Exposure Therapy then Step up to Primary Care Treatment Integrating Motivation and Exposure

    Behavioral: Written Exposure Therapy (WET) · Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)

  • Experimental
    Clinician Supported PTSD Coach App (CS-PTSD) then Phone follow up

    Behavioral: Clinician Supported PTSD Coach App (CS-PTSD) · Behavioral: Phone follow up

  • Experimental
    CS-PTSD then continue with CS-PTSD

    Behavioral: Clinician Supported PTSD Coach App (CS-PTSD)

  • Experimental
    CS-PTSD then Step up to PC-TIME

    Behavioral: Clinician Supported PTSD Coach App (CS-PTSD) · Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)

Interventions

  • BehavioralWritten Exposure Therapy (WET)

    WET is a five-session, evidence-based PTSD protocol that can be delivered in as little as 30 minutes.18 Treatment consists of structured writing assignments about the trauma in session, with the support of a clinician. WET does not contain between-session assignments.

  • BehavioralClinician Supported PTSD Coach App (CS-PTSD)

    CS-PTSD Coach combines the free-to-use PTSD Coach mobile app with clinician support, which has been shown to increase app engagement and lead to greater reductions in PTSD symptom severity.16,22 CS-PTSD Coach will consist of five 30-minute sessions in which therapists work with patients to personalize PTSD Coach's psychoeducational and self-management components.

  • BehavioralPhone follow up

    Phone follow-up, which will occur 2- and 4-weeks after session 5.

  • BehavioralPrimary Care Treatment Integrating Motivation and Exposure (PC-TIME)

    PC-TIME consists of five 30-minute sessions, with daily homework assigned between sessions.

06

What researchers measure

Primary outcomes

  1. Participant rating of acceptability of intervention

    Measured using a 7 item Intervention Acceptability scale. The scale ranges from 0- 28. Higher scores indicate greater acceptability.

    Time frame: Session 10, Approximately week 15

  2. Percent of participants who engage and complete follow-up timepoints

    For the purposes of this study complete is defined as 80%

    Time frame: Session 10, Approximately week 15

  3. Percent of participants who are eligible agree to participate

    Time frame: Session 10, Approximately week 15

  4. Percent of participants who complete daily symptom monitoring

    For the purposes of this study complete is defined as 80%

    Time frame: Session 10, Approximately week 15

Secondary outcomes

  1. Change in PTSD symptom severity (as measured by the PTSD Symptom Checklist for DSM-5)

    The study team is planning on measuring change at each timepoint. Baseline to visit 5, baseline to visit 10, and visit 5 to visit 10. The checklist is 20 items and each item has a scale of 0 to 4 (total range of 0-80). Higher scores indicate greater symptom severity.

    Time frame: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)

  2. Change in alcohol use (as measured by the Timeline Follow Back)

    The study team is planning on measuring change at each timepoint. Baseline to visit 5, baseline to visit 10, and visit 5 to visit 10.

    Time frame: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903974
Responsible party
Peter Grau (Assistant Professor, University of Michigan Department of Psychiatry, University of Michigan) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2031 (estimated)
Completion
Oct 2031 (estimated)
Last update
Oct 29, 2026

Study contacts

James Garlick
Contact
jgarlick@med.umich.edu
(734) 232-2663
Peter Grau, PhD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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