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

• ClinicalTrials.gov Identifier: NCT00108628
• Recruitment Status: Completed
• First Posted: April 18, 2005
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-traumatic Stress Disorder	Behavioral: Imagery Rehearsal; Behavioral: Sleep and Nightmare Management	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
• Study Start Date: April 2004
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Weekly Number of Nightmares [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]
2. Weekly Nights With a Nightmare [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]
3. 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.

Secondary Outcome Measures :

1. Pittsburgh Sleep Quality Index - Addendum [ Time Frame: 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.
2. Nightmare Effects Survey [ Time Frame: 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.
3. PTSD Military Checklist [ Time Frame: 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.
4. Beck Depression Inventory [ Time Frame: 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.
5. SF-36 Physical Component [ Time Frame: 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").
6. SF-36 Mental Component [ Time Frame: 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").
7. Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Richard J. Ross, MD PhD; Corporal Michael J. Crescenz VA Medical Center

More Information

Publications of Results:

Harb GC, Thompson R, Ross RJ, Cook JM. Combat-related PTSD nightmares and imagery rehearsal: nightmare characteristics and relation to treatment outcome. J Trauma Stress. 2012 Oct;25(5):511-8. doi: 10.1002/jts.21748. Epub 2012 Oct 9.

Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, Ross RJ. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010 Oct;23(5):553-63. doi: 10.1002/jts.20569.

Cook JM, Thompson R, Harb GC, Ross RJ. Cognitive-behavioral treatment for posttraumatic nightmares: An investigation of predictors of dropout and outcome. Psychological trauma : theory, research, practice and policy. 2013 Nov 1; 5(6):545-553.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00108628
• Other Study ID Numbers: CLIN-018-03S
• First Posted: April 18, 2005
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Last Verified: February 2015

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Imagery; Nightmares; Post-Traumatic Stress Disorder; Psychotherapy

Additional relevant MeSH terms:

Dyssomnias; Parasomnias; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases