Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-1-0782 | Other Grant/Funding Number | Department of Defense (DOD) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Invisible Wounds Project | UNKNOWN |
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Treatment as usual (TAU) | No Intervention | Participants in this arm will receive treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted STAIR-NT | Behavioral | An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 4-6 weeks, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4-6 weeks, 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Schwartz, PhD | Contact | 850-644-7949 | jaschwartz@fsu.edu | |
| Tanya Renn, PhD | Contact | 850-645-0903 | trenn@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Schwartz, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invisible Wounds Project | Forest Lake | Minnesota | 55025 | United States |
Not provided
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D000070642 | Brain Injuries, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D062525 | Narrative Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Pilot randomized control trial with an intervention arm and a treatment-as-usual arm.
Not provided
Not provided
Not provided
Not provided
| 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). | Baseline, 4-6 weeks, 3 months, 6 months |
| 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. | Baseline, 4-6 weeks, 3 months, 6 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. | Baseline, 4-6 weeks, 3 months, 6 months |
| 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). | Baseline, 4-6 weeks, 3 months, 6 months |
| 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" | Baseline, 4-6 weeks, 3 months, 6 months |
| 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. | Baseline, 4-6 weeks, 3 months, 6 months |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |