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Not yet recruitingNCT07212140Updated Aug 25, 2026

Adaptation of the STAIR-NT for First Responders

An interventional study of Adapted STAIR-NT in PTSD - Post Traumatic Stress Disorder and TBI-Traumatic Brain Injury, sponsored by Florida State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • PTSD - Post Traumatic Stress Disorder
  • TBI-Traumatic Brain Injury

Keywords

  • PTSD
  • TBI
  • First responders
  • STAIR-NT
  • GMT
03

Who can participate

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

Inclusion criteria

  • 18 years or older
  • be a first responder within the state of Minnesota
  • have a history of a TBI
  • screen for PTSD.

Exclusion criteria

Exclusion Criteria:

  • Does not meet inclusion criteria.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Adapted STAIR-NT Intervention

    Participants in this arm will receive the adapted version of Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT).

    Behavioral: Adapted STAIR-NT

  • No intervention
    Treatment as usual (TAU)

    Participants in this arm will receive treatment as usual.

Interventions

  • BehavioralAdapted STAIR-NT

    An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.

    Also known as: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

Secondary outcomes

  1. 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).

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  2. 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).

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  3. 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.

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  4. 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.

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

Other outcomes

  1. Change in General Well Being

    The General Well Being Schedule (GWB) is an 18-item, self-administered questionnaire that includes positive and negative questions tapping six dimensions: positive well-being, self-control, vitality, depression, anxiety, and general health. Statements ask participants to indicate feelings in the past 30 days. Lower scores indicate lower overall well-being.

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  2. Changes in Health Conditions

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 12-item questionnaire tapping difficulties due to health conditions. Participants report difficulties in physical, cognitive, and social tasks in the past 30 days. Provided response categories range between 0 (none) and 4 (extreme or cannot do).

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  3. Change in Social Support

    The Medical Outcomes Study (MOS) Social Support Survey is a 19-item self-administered questionnaire tapping four functional support domains: positive social interaction, emotional/informational support; tangible/instrumental support; and affectionate support. Provided response categories range from "none of the time" to "all of the time"

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

  4. Changes in Chronic Pain

    The Brief Pain Inventory-Short Form (BPI-SF), is a 15-item self-administered questionnaire that assesses the severity and impact of pain.

    Time frame: Baseline, 4-6 weeks, 3 months, 6 months

06

Study locations

1 site
  • Invisible Wounds Project
    Forest Lake, Minnesota 55025, United States
07

Registry details

Key details

Study ID
NCT07212140
Lead sponsor
Florida State University
Collaborators
Invisible Wounds Project, United States Department of Defense
Responsible party
Joseph Schwartz (Associate Professor, Florida State University) — Principal investigator
First posted
Oct 8, 2025
Start date
Nov 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

Joseph Schwartz, PhD
Contact
jaschwartz@fsu.edu
850-644-7949
Tanya Renn, PhD
Contact
trenn@fsu.edu
850-645-0903
Joseph Schwartz, PhD
principal investigator · Florida State University

Oversight

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

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