Adaptation of the STAIR-NT for First Responders

NCT07212140 | Not Yet Recruiting

• 2 other identifiers: STUDY00005143HT9425-24-1-0782
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PTSD; TBI; First responders; STAIR-NT; GMT

Outcome Measures

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).

  Baseline, 4-6 weeks, 3 months, 6 months

Secondary Outcomes (4)

• Change in Anxiety Symptoms

  Baseline, 4-6 weeks, 3 months, 6 months

• Change in Depression Symptoms

  Baseline, 4-6 weeks, 3 months, 6 months

• Change in Alcohol Use

  Baseline, 4-6 weeks, 3 months, 6 months

• Change in Drug Use

  Baseline, 4-6 weeks, 3 months, 6 months

Other Outcomes (4)

• Change in General Well Being

  Baseline, 4-6 weeks, 3 months, 6 months

• Changes in Health Conditions

  Baseline, 4-6 weeks, 3 months, 6 months

• Change in Social Support

  Baseline, 4-6 weeks, 3 months, 6 months

Study Arms (2)

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).

Behavioral: Adapted STAIR-NT

Treatment as usual (TAU)

NO INTERVENTION

Participants in this arm will receive treatment as usual.

Interventions

Adapted STAIR-NT BEHAVIORAL

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

Adapted STAIR-NT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Florida State University: lead
• Invisible Wounds Project: collaborator

Study Sites (1)

Invisible Wounds Project

Forest Lake, Minnesota, 55025, United States

Location

MeSH Terms

Conditions

Combat Disorders; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Interventions

Narrative Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joseph Schwartz, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Schwartz, PhD

CONTACT

850-644-7949; jaschwartz@fsu.edu

Tanya Renn, PhD

CONTACT

850-645-0903; trenn@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot randomized control trial with an intervention arm and a treatment-as-usual arm.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 8, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)