Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance
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Purpose
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
| Condition | Intervention |
|---|---|
|
Post-traumatic Stress Disorder |
Behavioral: Imagery Rehearsal Behavioral: Sleep and Nightmare Management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance |
- Nightmare Frequency Questionnaire [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 124 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Imagery Rehearsal Therapy
|
Behavioral: Imagery Rehearsal
IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
|
|
Active Comparator: Arm 2
Sleep and Nightmare Management
|
Behavioral: Sleep and Nightmare Management
This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
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Detailed Description:
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male
- Vietnam Combat Veteran
- Diagnosis of combat-related PTSD
- Stable psychotropic regimen for a minimum of three months
- Experiences recurrent nightmares
Exclusion Criteria:
- Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
- Schizophrenia and other psychotic disorders
- Substance abuse or dependence within the last six months
- Untreated medical disorders known to impact sleep
Contacts and Locations| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Richard Ross, MD PhD | VA Medical Center, Philadelphia |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108628 History of Changes |
| Other Study ID Numbers: | CLIN-018-03S |
| Study First Received: | April 15, 2005 |
| Last Updated: | December 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Imagery Nightmares Post-Traumatic Stress Disorder Psychotherapy |
Additional relevant MeSH terms:
|
Sleep Disorders Dyssomnias Parasomnias Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 23, 2013