This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
The aims of the study are: 1. Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD. 2. Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD. Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
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.
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.
WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.
Fort Hood
Kileen, Texas, United States
RECRUITINGPosttraumatic Stress Disorder Checklist (PCL-5)
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Time frame: Change from baseline through 3 and 6 month follow-up assessment
Insomnia Severity Index (ISI)
The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).
Time frame: Change from baseline through 3 and 6 month follow up
Nightmare Disorders Index
The NDI is a self-report assessment of nightmare disorder.
Time frame: Change from baseline through 3 and 6 month assessments
Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Time frame: Change from baseline to 1-month follow-up assessment
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.
Time frame: Change from baseline to 1-month follow-up assessment
Generalized Anxiety Disorder Screener (GAD-7)
GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety).
Time frame: Change from baseline through 3 and 6 month follow-up assessment
Trauma-Related Nightmare Survey (TRNS)
The TRNS assesses nightmare frequency, disturbance, and characteristics
Time frame: Change from baseline through 3 and 6 month follow-up assessment
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. Total scores range from 0-12 (higher scores indicate greater suicidality).
Time frame: Change from baseline through 3 and 6 month follow up assessment
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 assess the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder. Total scores range from 0-27 (higher scores indicate greater depressive symptom severity).
Time frame: Change from baseline through 3 and 6 follow-up assessment
Brief Inventory of Psychosocial Functioning (B-IPF)
B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Total scores range from 0-42 (higher scores indicate greater functional impairment).
Time frame: Change from baseline through 3 and 6 month follow up
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