Insomnia Clinical Trial
Official title:
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; 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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | NDRI_USA | Kansas City | Missouri |
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 |
United States,
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) |
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