PTSD - Post Traumatic Stress DisorderNCT07212140
Adaptation of the STAIR-NT for First Responders
A study testing Adapted STAIR-NT in people with PTSD - Post Traumatic Stress Disorder and TBI-Traumatic Brain Injury, run by Florida State University at 1 site in United States.
Trial summary
This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, TBI-Traumatic Brain Injury
- What is being tested?
- Adapted STAIR-NT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 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
- 18 years or older
- be a first responder within the state of Minnesota
- have a history of a TBI
- screen for PTSD.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Invisible Wounds Project
Forest Lake, Minnesota, 55025
Russ Hanes, (763) 486-3079, russ@iwproject.org
About this study
Official title: Adaptation of the STAIR-NT Intervention to Respond to Psychological Health Conditions for First Responders With a History of Traumatic Brain Injury
This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.
Read the detailed description
The primary objective of the study is to implement and evaluate the effectiveness of an evidence-based intervention, STAIR-NT, which will be adapted with Goal Management Training (GMT). A small-scale randomized control pilot will be conducted using the adapted intervention to examine implementation (i.e., feasibility, acceptability) and improvements in short-term PTSD, as well as secondary mental health outcomes (e.g., anxiety, and depression symptoms, substance misuse) among a first responder population with a history of TBI and PTSD.
- Being tested
- Adapted STAIR-NT
- Keywords
- PTSD, TBI, First responders, STAIR-NT, GMT
- Medical subject headings
- Combat Disorders, Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted STAIR-NTBehavioural
Also called Skills Training in Affective and Interpersonal Regulation with Narrative Therapy
An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.
| Study group | Role | What they receive |
|---|---|---|
| Adapted STAIR-NT Intervention | Experimental | Participants in this arm will receive the adapted version of Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT). Receives: Behavioral: Adapted STAIR-NT |
| Treatment as usual (TAU) | No intervention | Participants in this arm will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Disorder Symptoms
The 20-item PTSD Checklist for DSM-5 (PCL-5) will be used to assess PTSD symptoms. All items are scored on a 5-point Likert scale ranging between 0 (not at all) and 4 (extremely).
Measured: Baseline, 4-6 weeks, 3 months, 6 months
Secondary outcomes (4)
Change in Anxiety Symptoms
The Generalized Anxiety Disorder Screener-7 (GAD-7) will be used to assess anxiety symptoms. The included items ask participants to indicate how frequently they experienced seven symptoms over the past two weeks, with provided response categories ranging between 0 (not at all) to 3 (nearly every day).
Measured: Baseline, 4-6 weeks, 3 months, 6 months
Change in Depression Symptoms
The Patient Health Questionnarie-9 (PHQ-9) is an abbreviated version of the full PHQ focused on major depressive disorder and will be used to assess depression symptoms. Participants are asked to indicate how often they experienced nine different feelings over the past two weeks with possible response categories ranging between 0 (not at all) and 3 (nearly every day).
Measured: Baseline, 4-6 weeks, 3 months, 6 months
Change in Alcohol Use
The Alcohol Use Disorders Identification Test (AUDIT) is a self-administered instrument that includes 10 screening questions tapping alcohol use and alcohol-related consequences in the past 12 months.
Measured: Baseline, 4-6 weeks, 3 months, 6 months
Change in Drug Use
The Drug Abuse Screening Test (DAST-10) is a 10-item questionnaire tapping the use of drugs and related health effects and behaviors over the past 12 months.
Measured: Baseline, 4-6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Parallel groups
- Model description
- Pilot randomized control trial with an intervention arm and a treatment-as-usual arm.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Invisible Wounds Project, United States Department of Defense
- Responsible party
- Principal investigator, Joseph Schwartz, Florida State University
- Investigators
- Joseph Schwartz, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212140
- Sponsor's protocol ID
- STUDY00005143
- Other IDs
- HT9425-24-1-0782
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the STAIR-NT Intervention to Respond to Psychological Health Conditions for First Responders With a History of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07212140
- Acronym / sponsor ID
- STUDY00005143
- Keywords
- PTSD, TBI, First responders, STAIR-NT, GMT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Invisible Wounds Project, United States Department of Defense
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Oct 2025 (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 study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.
Detailed description
The primary objective of the study is to implement and evaluate the effectiveness of an evidence-based intervention, STAIR-NT, which will be adapted with Goal Management Training (GMT). A small-scale randomized control pilot will be conducted using the adapted intervention to examine implementation (i.e., feasibility, acceptability) and improvements in short-term PTSD, as well as secondary mental health outcomes (e.g., anxiety, and depression symptoms, substance misuse) among a first responder population with a history of TBI and PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized control trial with an intervention arm and a treatment-as-usual arm.
| Arm | Type | Receives |
|---|---|---|
| Adapted STAIR-NT Intervention | Experimental | Behavioral: Adapted STAIR-NTParticipants in this arm will receive the adapted version of Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT). |
| Treatment as usual (TAU) | No intervention | –Participants in this arm will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- be a first responder within the state of Minnesota
- have a history of a TBI
- screen for PTSD.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
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 |
|---|---|---|
| Adapted STAIR-NTAlso: Skills Training in Affective and Interpersonal Regulation with Narrative TherapyAn adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI. | Behavioural | Adapted STAIR-NT Intervention |
Primary outcome
Change in Post-Traumatic Stress Disorder Symptoms
Time frame: Baseline, 4-6 weeks, 3 months, 6 months
The 20-item PTSD Checklist for DSM-5 (PCL-5) will be used to assess PTSD symptoms. All items are scored on a 5-point Likert scale ranging between 0 (not at all) and 4 (extremely).
4 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline, 4-6 weeks, 3 months, 6 months
Change in Depression Symptoms
Time frame: Baseline, 4-6 weeks, 3 months, 6 months
Change in Alcohol Use
Time frame: Baseline, 4-6 weeks, 3 months, 6 months
Change in Drug Use
Time frame: Baseline, 4-6 weeks, 3 months, 6 months
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 25 Aug 2026.
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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.
Joseph Schwartz, PhD principal investigator
Florida 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 Adapted STAIR-NT in people with PTSD - Post Traumatic Stress Disorder and TBI-Traumatic Brain Injury, run by Florida 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Aug 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?
Contact Joseph Schwartz, PhD (850-644-7949, jaschwartz@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Traumatic Stress Disorder Symptoms (time frame: Baseline, 4-6 weeks, 3 months, 6 months). 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 25 Aug 2026.