Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance
7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 15, 2005
CompletedFirst Posted
Study publicly available on registry
April 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
February 1, 2015
4.4 years
April 15, 2005
December 3, 2014
February 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Pittsburgh Sleep Quality Index
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.
Baseline and 1, 3, and 6 months post-treatment
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALImagery Rehearsal Therapy
Arm 2
ACTIVE COMPARATORSleep and Nightmare Management
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Male
- Vietnam Combat Veteran
- Diagnosis of combat-related PTSD
- Stable psychotropic regimen for a minimum of three months
- Experiences recurrent nightmares
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
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.
PMID: 23047646RESULTCook 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.
PMID: 20839311RESULTCook 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Ross
- Organization
- Philadelphia VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J. Ross, MD PhD
Corporal Michael J. Crescenz VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2005
First Posted
April 18, 2005
Study Start
April 1, 2004
Primary Completion
September 1, 2008
Study Completion
July 1, 2013
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2015-02