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NCT05950035 · ClinicalTrials.gov registry record · NA

An Efficient Treatment for Posttraumatic Injury for Firefighters

A NA study of Insomnia and Posttraumatic Stress Disorder, sponsored by Palo Alto Veterans Institute for Research.

Completed
Registry status
NA
Development phase
49
Enrollment target
1
Study location

NCT05950035 is a NA study of Insomnia and Posttraumatic Stress Disorder that has completed, run by Palo Alto Veterans Institute for Research. The registered enrollment target is 49 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05950035, a NA study of Insomnia and Posttraumatic Stress Disorder, has completed, sponsored by Palo Alto Veterans Institute for Research.

COMPLETED
Registry status
NA
Development phase
49 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy for Nightmares (CBTn)
  • BEHAVIORAL Written Exposure Therapy (WET)
  • BEHAVIORAL Waitlist
  • BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBTi)

Study Locations (1)

Missouri

  • NDRI_USA - Kansas City

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2023-12-01
Est. Completion 2025-01-01
Phase NA

What the Registry Record Tells You About NCT05950035

The ClinicalTrials.gov registry entry for NCT05950035 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (71% lower). The listed sponsor is Palo Alto Veterans Institute for Research, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 4 interventions - of which Cognitive Behavioral Therapy for Nightmares (CBTn) is the first listed.

NCT05950035 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT05950035 about?

NCT05950035 is a clinical study titled "An Efficient Treatment for Posttraumatic Injury for Firefighters". 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; C...

What is the current status of trial NCT05950035?

This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2023-12-01. Estimated completion is 2025-01-01.

What conditions does trial NCT05950035 study?

This clinical trial studies the following conditions: Insomnia, Posttraumatic Stress Disorder, Nightmare.

What interventions are being tested in trial NCT05950035?

The interventions under investigation include: Cognitive Behavioral Therapy for Nightmares (CBTn) (BEHAVIORAL), Written Exposure Therapy (WET) (BEHAVIORAL), Waitlist (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia (CBTi) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05950035?

This trial is sponsored by Palo Alto Veterans Institute for Research, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05950035 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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