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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Adapted STAIR-NT
BehavioralAn adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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).
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.
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.
Other outcomes
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.
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).
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"
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.
Sponsors and contacts
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Florida State University
Lead sponsor
Invisible Wounds Project
Collaborator
United States Department of Defense
Collaborator
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