Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Behavioral: Imagery Rehearsal; Behavioral: Sleep and Nightmare Management

• Registration Number: NCT00108628
• Lead Sponsor: US Department of Veterans Affairs

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-04-15
• Study First Submitted QC: 2005-04-15
• Study First Posted: 2005-04-18
• Primary Completion: 2008-09
• Study Completion: 2013-07
• Results First Submitted: 2014-12-03
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-17
• Last Update Submitted: 2015-02-17
• Results First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Male
• Vietnam Combat Veteran
• Diagnosis of combat-related PTSD
• Stable psychotropic regimen for a minimum of three months
• Experiences recurrent nightmares

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Imagery Rehearsal	Imagery Rehearsal Therapy
Arm 2	Sleep and Nightmare Management	Sleep and Nightmare Management

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	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	Baseline and 1, 3, and 6 months post-treatment
Weekly Nights With a Nightmare	Baseline and 1, 3, and 6 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index - Addendum	Baseline and 1, 3, and 6 months post-treatment	The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.
Nightmare Effects Survey	Baseline and 1, 3, and 6 months post-treatment	This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.
PTSD Military Checklist	Baseline and 1, 3, and 6 months post-treatment	Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.
Beck Depression Inventory	Baseline and 1, 3, and 6 months post-treatment	Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.
SF-36 Physical Component	Baseline and 1, 3, and 6 months post-treatment	The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
SF-36 Mental Component	Baseline and 1, 3, and 6 months post-treatment	The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Clinician-Administered PTSD Scale (CAPS)	Baseline and 1 month post-treatment	Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.

Trial Locations

Locations (1)

Philadelphia VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States