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An Efficient Treatment for Posttraumatic Injury for Firefighters

Primary Purpose

Posttraumatic Stress Disorder, Insomnia, Nightmare

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Exposure Therapy (WET)
Cognitive Behavioral Therapy for Insomnia (CBTi)
Cognitive Behavioral Therapy for Nightmares (CBTn)
Waitlist
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-65 years old Firefighter Able to speak and read English Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15 Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly. Exclusion Criteria: Current suicide or homicide risk meriting crisis intervention Inability to speak and read English Inability to comprehend the baseline screening questionnaires Unwilling to remain abstinent from alcohol during treatment Serious mental health diagnosis such as bipolar disorder or psychosis.

Sites / Locations

  • NDRI_USA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Intervention

Delayed Intervention

Arm Description

Will begin treatment within 2 weeks of randomization.

Will be scheduled to begin treatment within 4-6 weeks of randomization.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.
Insomnia Severity Index (ISI)
The ISI assesses perceived severity of insomnia.
Nightmare Disorders Index
The NDI is a self-report assessment of nightmare disorder.
Posttraumatic Stress Disorder Checklist (PCL-5)
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.

Secondary Outcome Measures

Trauma-Related Nightmare Survey (TRNS)
The TRNS assesses nightmare frequency, disturbance, and characteristics.
Self-Assessment of Sleep (SASS)
The SASS is a brief assessment of self-reported sleep quantity and sleep quality.
Sleep Diary and Nightmare Log
The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide.
Net Prompter Score
The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.

Full Information

First Posted
June 5, 2023
Last Updated
July 14, 2023
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
University of Arizona, Oregon State University, Boston University, The University of Texas Health Science Center at San Antonio, National Development and Research Institutes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05950035
Brief Title
An Efficient Treatment for Posttraumatic Injury for Firefighters
Official Title
An Efficient Treatment for Posttraumatic Injury for Firefighters
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 18, 2023 (Anticipated)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
University of Arizona, Oregon State University, Boston University, The University of Texas Health Science Center at San Antonio, National Development and Research Institutes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Insomnia, Nightmare

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Will begin treatment within 2 weeks of randomization.
Arm Title
Delayed Intervention
Arm Type
Active Comparator
Arm Description
Will be scheduled to begin treatment within 4-6 weeks of randomization.
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure Therapy (WET)
Intervention Description
WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBTi)
Intervention Description
CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Nightmares (CBTn)
Intervention Description
CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Waitlist for delayed intervention.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS-5)
Description
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.
Time Frame
Change from baseline to post treatment (~4 weeks post baseline)
Title
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
Description
The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.
Time Frame
Change from baseline to post treatment (~4 weeks post baseline)
Title
Insomnia Severity Index (ISI)
Description
The ISI assesses perceived severity of insomnia.
Time Frame
Change from baseline through 3 months post treatment
Title
Nightmare Disorders Index
Description
The NDI is a self-report assessment of nightmare disorder.
Time Frame
Change from baseline through 3 months post treatment
Title
Posttraumatic Stress Disorder Checklist (PCL-5)
Description
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.
Time Frame
Change from baseline through 3 months post treatment
Secondary Outcome Measure Information:
Title
Trauma-Related Nightmare Survey (TRNS)
Description
The TRNS assesses nightmare frequency, disturbance, and characteristics.
Time Frame
Change from baseline through 3 months post treatment
Title
Self-Assessment of Sleep (SASS)
Description
The SASS is a brief assessment of self-reported sleep quantity and sleep quality.
Time Frame
Change from baseline through 3 months post treatment
Title
Sleep Diary and Nightmare Log
Description
The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.
Time Frame
Change from baseline through post treatment (~4 weeks post baseline)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.
Time Frame
Change from baseline through 3 months post treatment
Title
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Description
The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide.
Time Frame
Change from baseline through 3 months post treatment
Title
Net Prompter Score
Description
The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.
Time Frame
Post treatment (~4 weeks post baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old Firefighter Able to speak and read English Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15 Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly. Exclusion Criteria: Current suicide or homicide risk meriting crisis intervention Inability to speak and read English Inability to comprehend the baseline screening questionnaires Unwilling to remain abstinent from alcohol during treatment Serious mental health diagnosis such as bipolar disorder or psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara A Jahnke, PhD
Phone
(913) 238-5648
Email
jahnke@ndri-usa.org
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Sutherland, MS
Phone
(913) 249-2985
Email
sutherland@ndri-usa.org
Facility Information:
Facility Name
NDRI_USA
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66224
Country
United States

12. IPD Sharing Statement

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An Efficient Treatment for Posttraumatic Injury for Firefighters

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