Adaptation of the STAIR-NT for First Responders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PTSD - Post Traumatic Stress Disorder; TBI-Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Adapted STAIR-NT

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanya Renn, PhD; Phone Number: 850-645-0903; Email: trenn@fsu.edu
• Study Contact Backup: Name: Joseph Schwartz, PhD; Phone Number: 850-644-7949; Email: jaschwartz@fsu.edu

Study Locations

• United States
  • Minnesota
    • Forest Lake, Minnesota, United States, 55025
      • Invisible Wounds Project
      • Contact: Russ Hanes; Phone Number: (763) 486-3079; Email: russ@iwproject.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• Does not meet inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.; Other Names: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy
No Intervention: Treatment as usual (TAU); Participants in this arm will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 4-6 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	Baseline, 4-6 weeks, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4-6 weeks, 3 months, 6 months
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).	Baseline, 4-6 weeks, 3 months, 6 months
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"	Baseline, 4-6 weeks, 3 months, 6 months
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.	Baseline, 4-6 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: United States Department of Defense; Invisible Wounds Project
• Investigators: Principal Investigator: Joseph Schwartz, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: September 30, 2025
• First Posted (Actual): October 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; TBI; GMT; First responders; STAIR-NT
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Stress Disorders, Traumatic; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders; Psychotherapy; Behavioral Disciplines and Activities; Narrative Therapy
• Other Study ID Numbers: STUDY00005143 (Emory University Hospital/Winship Cancer Institute); HT9425-24-1-0782 (Other Grant/Funding Number: Department of Defense (DOD))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No