Post Traumatic Stress Disorder PTSDNCT07903974
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
A study testing Written Exposure Therapy (WET), Clinician Supported PTSD Coach App (CS-PTSD) and Phone follow up in people with Post Traumatic Stress Disorder PTSD and Hazardous Alcohol Use, run by University of Michigan at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
- What is being tested?
- Written Exposure Therapy (WET), Clinician Supported PTSD Coach App (CS-PTSD) and Phone follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients will be eligible for the study if they:
- are age 18 years or older
- receive care at a participating Federally Qualified Health Center (FQHC)
- have a PTSD checklist (PCL)-5 score ≥28
- 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)
- have had psychotropic medication stability for at least 4 weeks
- speak English
Patients will be eligible for the qualitative portion of the study if they:
- Enrolled into the randomized controlled trial (RCT) AND
- Were a treatment responder OR
- Were a treatment non-responder
Patients will be excluded if they have:
- 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)
- 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)
- active psychosis or unmanaged bipolar disorder
- current engagement in a trauma- or alcohol-focused treatment 7) Patients who do not speak English will be excluded for logistical reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
James Garlick, 734-232-2663, jgarlick@med.umich.edu
Peter Grau, PhD
Zufull Health - Dover
Dover, New Jersey, 07801
Sarah Aleman, 973-328-9100, saleman@zufallhealth.org
Sarah Aleman
About this study
Official title: Developing a Multimodal Intervention for Individuals With PTSD and Hazardous Alcohol Use in Federally Qualified Health Centers
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.
- Being tested
- Written Exposure Therapy (WET), Clinician Supported PTSD Coach App (CS-PTSD), Phone follow up, Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)
- Keywords
- stepped care models, federally qualified health centers
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure Therapy (WET)Behavioural
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.
Clinician Supported PTSD Coach App (CS-PTSD)Behavioural
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.
Phone follow upBehavioural
Phone follow-up, which will occur 2- and 4-weeks after session 5.
Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)Behavioural
PC-TIME consists of five 30-minute sessions, with daily homework assigned between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy (WET) then Phone follow up | Experimental | Not described Receives: Behavioral: Written Exposure Therapy (WET); Behavioral: Phone follow up |
| Written Exposure Therapy (WET) then continue with WET | Experimental | Not described Receives: Behavioral: Written Exposure Therapy (WET) |
| Written Exposure Therapy then Step up to Primary Care Treatment Integrating Motivation and Exposure | Experimental | Not described Receives: Behavioral: Written Exposure Therapy (WET); Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME) |
| Clinician Supported PTSD Coach App (CS-PTSD) then Phone follow up | Experimental | Not described Receives: Behavioral: Clinician Supported PTSD Coach App (CS-PTSD); Behavioral: Phone follow up |
| CS-PTSD then continue with CS-PTSD | Experimental | Not described Receives: Behavioral: Clinician Supported PTSD Coach App (CS-PTSD) |
| CS-PTSD then Step up to PC-TIME | Experimental | Not described Receives: Behavioral: Clinician Supported PTSD Coach App (CS-PTSD); Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Session 10, Approximately week 15
Percent of participants who engage and complete follow-up timepoints
For the purposes of this study complete is defined as 80%
Measured: Session 10, Approximately week 15
Percent of participants who are eligible agree to participate
Measured: Session 10, Approximately week 15
Percent of participants who complete daily symptom monitoring
For the purposes of this study complete is defined as 80%
Measured: Session 10, Approximately week 15
Secondary outcomes (2)
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.
Measured: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)
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.
Measured: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Peter Grau, University of Michigan
- Investigators
- Peter Grau, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903974
- Sponsor's protocol ID
- HUM00275096
- Other IDs
- 1K23MH141149-01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Multimodal Intervention for Individuals With PTSD and Hazardous Alcohol Use in Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT07903974
- Acronym / sponsor ID
- HUM00275096
- Keywords
- stepped care models, federally qualified health centers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the case of uneven dropout across interventions, the research team will recruit additional patients until target sample is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy (WET) then Phone follow up | Experimental | Behavioral: Written Exposure Therapy (WET), Behavioral: Phone follow up |
| Written Exposure Therapy (WET) then continue with WET | Experimental | Behavioral: Written Exposure Therapy (WET) |
| Written Exposure Therapy then Step up to Primary Care Treatment Integrating Motivation and Exposure | Experimental | Behavioral: Written Exposure Therapy (WET), Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME) |
| Clinician Supported PTSD Coach App (CS-PTSD) then Phone follow up | Experimental | Behavioral: Clinician Supported PTSD Coach App (CS-PTSD), Behavioral: Phone follow up |
| CS-PTSD then continue with CS-PTSD | Experimental | Behavioral: Clinician Supported PTSD Coach App (CS-PTSD) |
| CS-PTSD then Step up to PC-TIME | Experimental | Behavioral: Clinician Supported PTSD Coach App (CS-PTSD), Behavioral: Primary Care Treatment Integrating Motivation and Exposure (PC-TIME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written 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. | Behavioural | Written Exposure Therapy (WET) then Phone follow up, Written Exposure Therapy (WET) then continue with WET, Written Exposure Therapy then Step up to Primary Care Treatment Integrating Motivation and Exposure |
| Clinician 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. | Behavioural | CS-PTSD then Step up to PC-TIME, CS-PTSD then continue with CS-PTSD, Clinician Supported PTSD Coach App (CS-PTSD) then Phone follow up |
| Phone follow upPhone follow-up, which will occur 2- and 4-weeks after session 5. | Behavioural | Clinician Supported PTSD Coach App (CS-PTSD) then Phone follow up, Written Exposure Therapy (WET) then Phone follow up |
| Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)PC-TIME consists of five 30-minute sessions, with daily homework assigned between sessions. | Behavioural | CS-PTSD then Step up to PC-TIME, Written Exposure Therapy then Step up to Primary Care Treatment Integrating Motivation and Exposure |
Primary outcome
Participant rating of acceptability of intervention
Time frame: Session 10, Approximately week 15
Measured using a 7 item Intervention Acceptability scale. The scale ranges from 0- 28. Higher scores indicate greater acceptability.
Percent of participants who engage and complete follow-up timepoints
Time frame: Session 10, Approximately week 15
For the purposes of this study complete is defined as 80%
Percent of participants who are eligible agree to participate
Time frame: Session 10, Approximately week 15
Percent of participants who complete daily symptom monitoring
Time frame: Session 10, Approximately week 15
For the purposes of this study complete is defined as 80%
2 secondary outcomes
Change in PTSD symptom severity (as measured by the PTSD Symptom Checklist for DSM-5)
Time frame: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)
Change in alcohol use (as measured by the Timeline Follow Back)
Time frame: Baseline, Session 5, Session 10 (Approximately week 1, 8, 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Grau, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy (WET), Clinician Supported PTSD Coach App (CS-PTSD) and Phone follow up in people with Post Traumatic Stress Disorder PTSD and Hazardous Alcohol Use, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Garlick ((734) 232-2663, jgarlick@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant rating of acceptability of intervention (time frame: Session 10, Approximately week 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.