Adaptation of the STAIR-NT for First Responders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

be a first responder within the state of Minnesota

have a history of a TBI

screen for PTSD.

Disqualifiers

Does not meet inclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted STAIR-NT

    Behavioral

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Adapted STAIR-NT InterventionExperimental treatment 1 intervention
Group B: Treatment as usual (TAU)No intervention 0 interventions

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

Invisible Wounds Project

Collaborator

United States Department of Defense

Collaborator

This trial is not recruiting at the moment. You can still explore other options: