An Efficient Treatment for Posttraumatic Injury for Firefighters

Insomnia Clinical Trial

Official title:

An Efficient Treatment for Posttraumatic Injury for Firefighters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950035
• Other study ID #: MCA0006AGG
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: January 2024
• Source: Palo Alto Veterans Institute for Research
• Contact: Sara A Jahnke, PhD
• Phone: (913) 238-5648
• Email: jahnke[@]ndri-usa.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Nightmare
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Written Exposure Therapy (WET)
WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
• Cognitive Behavioral Therapy for Insomnia (CBTi)
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.
• Cognitive Behavioral Therapy for Nightmares (CBTn)
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.
• Waitlist
Waitlist for delayed intervention.

Locations

Country	Name	City	State
United States	NDRI_USA	Kansas City	Missouri

Sponsors (6)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Boston University, National Development and Research Institutes, Inc., Oregon State University, The University of Texas Health Science Center at San Antonio, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS-5)	The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.	Change from baseline to post treatment (~4 weeks post baseline)
Primary	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.	Change from baseline to post treatment (~4 weeks post baseline)
Primary	Insomnia Severity Index (ISI)	The ISI assesses perceived severity of insomnia.	Change from baseline through 3 months post treatment
Primary	Nightmare Disorders Index	The NDI is a self-report assessment of nightmare disorder.	Change from baseline through 3 months post treatment
Primary	Posttraumatic Stress Disorder Checklist (PCL-5)	Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.	Change from baseline through 3 months post treatment
Secondary	Trauma-Related Nightmare Survey (TRNS)	The TRNS assesses nightmare frequency, disturbance, and characteristics.	Change from baseline through 3 months post treatment
Secondary	Self-Assessment of Sleep (SASS)	The SASS is a brief assessment of self-reported sleep quantity and sleep quality.	Change from baseline through 3 months post treatment
Secondary	Sleep Diary and Nightmare Log	The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.	Change from baseline through post treatment (~4 weeks post baseline)
Secondary	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.	Change from baseline through 3 months post treatment
Secondary	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.	Change from baseline through 3 months post treatment
Secondary	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.	Post treatment (~4 weeks post baseline)