Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

Study Overview
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Brief Summary
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Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.

Official Title
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Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

Conditions
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Nightmares, Insomnia, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: PTSD + IRT/CBT-I
* Behavioral: PTSD + Supportive Care Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 or more deployments to OEF or OIF Exposure to Trauma Nightmares 2 or more times per week Insomnia for 1 month or more Live in greater San Diego County region Exclusion Criteria: Use of medications for sleep or nightmares in the past 2 weeks Current enrollment in psychotherapy for PTSD Current or recent substance or alcohol abuse or dependence Other untreated sleep disorders (e.g., sleep apnea)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for Insomnia<br>Patients change their sleep times and habits in order to reduce alertness and over thinking when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time | Behavioral: PTSD + IRT/CBT-I<br>* 6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia<br>* Other names: Cognitive Behavioral Therapy for Insomnia;|
| Experimental: Imagery Rehearsal Therapy<br>Patients rescript the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too. | Behavioral: PTSD + IRT/CBT-I<br>* 6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia<br>* Other names: Cognitive Behavioral Therapy for Insomnia;|
| Experimental: Prolonged Exposure<br>This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations. | Behavioral: PTSD + IRT/CBT-I<br>* 6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia<br>* Other names: Cognitive Behavioral Therapy for Insomnia;Behavioral: PTSD + Supportive Care Therapy<br>* 6 weeks of prolonged exposure + 12 weeks of supportive care therapy<br>* Other names: exposure therapy;|
| Active Comparator: Suportive Care Therapy<br>This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms. | Behavioral: PTSD + Supportive Care Therapy<br>* 6 weeks of prolonged exposure + 12 weeks of supportive care therapy<br>* Other names: exposure therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nightmares and insomnia symptoms |  | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daytime (non-sleep) PTSD symptoms |  | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | 
| health-related quality of life |  | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD