Posttraumatic Stress DisorderNCT05564663
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
A study testing PTSD Coach App + Brief Support in people with Posttraumatic Stress Disorder and Alcohol Use Disorder, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Alcohol Use Disorder
- What is being tested?
- PTSD Coach App + Brief Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 31 May 2027
- 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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
About this study
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.
- Being tested
- PTSD Coach App + Brief Support, Enhanced Usual Care (EUC)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD Coach App + Brief SupportBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1-, 3-, 6-, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start6 Oct 2023
- Primary completion31 Aug 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kipling Bohnert, Michigan State University
- Investigators
- Kipling Bohnert, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564663
- Sponsor's protocol ID
- STUDY00006258
- Other IDs
- R01AA028213
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
- ClinicalTrials.gov ID
- NCT05564663
- Acronym / sponsor ID
- STUDY00006258
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD Coach App + Brief Support | Experimental | Behavioral: PTSD Coach App + Brief SupportPTSD 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. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| PTSD Coach App + Brief SupportPTSD 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). | Behavioural | PTSD Coach App + Brief Support |
| 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5) Change
Time frame: 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
Time frame: Baseline, 1-, 3-, 6-, and 12-months
The TLFB assessment method will be used to assess alcohol use in the past 30-days.
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 5 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. This study is not recruiting at the moment.
Kipling Bohnert principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD Coach App + Brief Support in people with Posttraumatic Stress Disorder and Alcohol Use Disorder, run by Michigan State University at 1 site 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 5 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) Change (time frame: Baseline, 1-, 3-, 6-, and 12-months). The study lists 2 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 5 Oct 2026.