Clinical trial NCT00108628: Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance
Official title: 7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Imagery
Nightmares
Post-Traumatic Stress Disorder
Psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-18
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Weekly Number of Nightmares
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: Weekly Nights With a Nightmare
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and 1, 3, and 6 months post-treatment
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index - Addendum
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: Nightmare Effects Survey
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: PTSD Military Checklist
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: Beck Depression Inventory
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: SF-36 Physical Component
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: SF-36 Mental Component
timeFrame: Baseline and 1, 3, and 6 months post-treatment
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Baseline and 1 month post-treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Richard J. Ross, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.