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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108628
First received: April 15, 2005
Last updated: February 17, 2015
Last verified: February 2015
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Weekly Number of Nightmares [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Weekly Nights With a Nightmare [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index - Addendum [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 1 month post-treatment ] [ Designated as safety issue: No ]
    Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.


Enrollment: 134
Study Start Date: April 2004
Study Completion Date: July 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

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108628

Locations
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Richard J. Ross, MD PhD Philadelphia VA Medical Center
  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
Results First Received: December 3, 2014
Last Updated: February 17, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Imagery
Nightmares
Post-Traumatic Stress Disorder
Psychotherapy

Additional relevant MeSH terms:
Dyssomnias
Parasomnias
Sleep Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 03, 2015