Adaptation of the STAIR-NT for First Responders

Not Applicable

Not yet recruiting

• Conditions: PTSD - Post Traumatic Stress Disorder; TBI-Traumatic Brain Injury

• Registration Number: NCT07212140
• Lead Sponsor: Florida State University

Brief 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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2026-06-01
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Post-Traumatic Stress Disorder Symptoms	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).

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety Symptoms	Baseline, 4-6 weeks, 3 months, 6 months	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).
Change in Depression Symptoms	Baseline, 4-6 weeks, 3 months, 6 months	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).
Change in Alcohol Use	Baseline, 4-6 weeks, 3 months, 6 months	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.
Change in Drug Use	Baseline, 4-6 weeks, 3 months, 6 months	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.

Trial Locations

Locations (1)

Invisible Wounds Project; 🇺🇸 Forest Lake, Minnesota, United States