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NCT Number: NCT07212140

Adaptation of the STAIR-NT for First Responders

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.

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Combat Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic TBI-Traumatic Brain Injury Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted STAIR-NT

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in Anxiety Symptoms

    Time frame: 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).

  2. Change in Depression Symptoms

    Time frame: 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).

  3. Change in Alcohol Use

    Time frame: 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.

  4. Change in Drug Use

    Time frame: 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.

Other outcomes

  1. Change in General Well Being

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

    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.

  2. Changes in Health Conditions

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

    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).

  3. Change in Social Support

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

    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"

  4. Changes in Chronic Pain

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Schwartz, PhD

CONTACT

[email protected]

850-644-7949

Tanya Renn, PhD

CONTACT

[email protected]

850-645-0903

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Invisible Wounds Project
  • United States Department of Defense

Registry information

Official study title

Adaptation of the STAIR-NT Intervention to Respond to Psychological Health Conditions for First Responders With a History of Traumatic Brain Injury

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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