Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning Veterans.

Detailed Description
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This is a dismantling study with the objective of determining whether imagery rehearsal is essential to the efficacy of imagery rehearsal + CBT-I for improving the sleep and nightmare disturbance in Veterans with PTSD and recurrent nightmares.

Official Title
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CBT for Nightmares in OEF/OIF Veterans

Conditions
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Posttraumatic Stress Disorder, Sleep Disorders, Nightmares

Intervention / Treatment
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* Behavioral: CBT for Insomnia plus Imagery Rehearsal
* Behavioral: CBT for Insomnia plus psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently enrolled in treatment in the Michael J. Crescenz VA Medical Center or VA Connecticut Healthcare System Mental Health Clinic Meets DSM-IV-R criteria for current PTSD (within the past month) Repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6 months) A global sleep disturbance, as indicated by a score of five or greater on the Pittsburgh Sleep Quality Index Ability to read and speak English A concurrent anxiety disorder or depressive disorder diagnosis will be allowed Dementia related to head injury and amnestic disorder related to head injury will be allowed Exclusion Criteria: Current substance dependence Bipolar disorder Delirium Dementia that is not related to head injury Amnestic disorder that is not related to head injury Schizophrenia and other psychotic disorders Severe traumatic brain injury, as indicated by self-report (loss of consciousness or alteration of mental status greater than 24 hours, or peri-traumatic memory loss, or any posttraumatic amnesia greater than 7 days) The presence of diagnosed sleep disorders other than insomnia: narcolepsy, circadian rhythm sleep disorders, and periodic limb movement disorder. Participants in treatment for sleep apnea, or who have not benefited from or declined available treatment may be included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: This is a randomized controlled trial comparing two forms of psychotherapy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: CBT for Insomnia plus Imagery Rehearsal<br>CBT for Insomnia plus Imagery Rehearsal | Behavioral: CBT for Insomnia plus Imagery Rehearsal<br>* patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress<br>|
| Active Comparator: Arm 2: CBT for Insomnia<br>CBT for Insomnia | Behavioral: CBT for Insomnia plus psychoeducation<br>* patients receive standard CBT for insomnia combined with psychoeducation<br>* Other names: Sleep and Nightmare Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire | The NFQ measures the number of nightmares/week and the number of nights with a nightmare/week. The NDQ measures the distress associated with nightmare experiences. | post-treatment, 3 month and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | This is a standard instrument for measuring basic sleep parameters. | post-treatment, 3 month and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress, nightmares, sleep, psychotherapy, imagery rehearsal, insomnia, behavioral treatment, veterans, Operation Iraqi Freedom, Operation Enduring Freedom