Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
Study NCT ID:
NCT05950035
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2023-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Efficient Treatment for Posttraumatic Injury for Firefighters
Sponsor:
Palo Alto Veterans Institute for Research
Organization:
Study Overview
Official Title:
An Efficient Treatment for Posttraumatic Injury for Firefighters
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:
* Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
* What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:
* Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
* Attend an individual treatment orientation session
* Attend a 4-day (\~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
* Attend an individual booster session held approximately one week later
* Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.
* Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
* What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:
* Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
* Attend an individual treatment orientation session
* Attend a 4-day (\~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
* Attend an individual booster session held approximately one week later
* Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: