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Clinical Trials/NCT00108628
NCT00108628
Completed
Not Applicable

7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance

US Department of Veterans Affairs1 site in 1 country134 target enrollmentApril 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder
Sponsor
US Department of Veterans Affairs
Enrollment
134
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
July 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index

Time Frame: Baseline and 1, 3, and 6 months post-treatment

Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.

Weekly Number of Nightmares

Time Frame: Baseline and 1, 3, and 6 months post-treatment

Weekly Nights With a Nightmare

Time Frame: Baseline and 1, 3, and 6 months post-treatment

Secondary Outcomes

  • Pittsburgh Sleep Quality Index - Addendum(Baseline and 1, 3, and 6 months post-treatment)
  • Nightmare Effects Survey(Baseline and 1, 3, and 6 months post-treatment)
  • PTSD Military Checklist(Baseline and 1, 3, and 6 months post-treatment)
  • Beck Depression Inventory(Baseline and 1, 3, and 6 months post-treatment)
  • SF-36 Physical Component(Baseline and 1, 3, and 6 months post-treatment)
  • SF-36 Mental Component(Baseline and 1, 3, and 6 months post-treatment)
  • Clinician-Administered PTSD Scale (CAPS)(Baseline and 1 month post-treatment)

Study Sites (1)

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