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Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
This study is currently recruiting participants.
Study NCT00881647   Information provided by National Institute of Mental Health (NIMH)
First Received: April 14, 2009   Last Updated: October 13, 2009   History of Changes

April 14, 2009
October 13, 2009
November 2008
February 2011   (final data collection date for primary outcome measure)
Sleep latency (SL), minutes of wake after sleep onset (WASO), and sleep efficiency [ Time Frame: Measured after 8 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881647 on ClinicalTrials.gov Archive Site
 
 
 
Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.

Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary insomnia but has been successfully used to treat insomnia in people with other disorders. Insomnia is the most commonly reported complaint of patients receiving treatment for post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in people with PTSD.

Participation in this study will last 10 months. At study entry, participants will complete a series of eligibility assessments, including a clinical interview, a medical screening, a urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week, participants will complete baseline assessments of sleep behaviors. The assessments will include the following: filling out a set of questionnaires about health, mood, sleeping patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like device, called an Actigraph, that records activity level during wakefulness and sleep; completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter, 1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep recorder connected to one's head to measure different stages of sleep.

After the week of sleep assessments, participants will be randomly assigned to one of two groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete eight weekly therapy sessions targeted at improving quality of sleep and resolving problems with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a questionnaire booklet with similar questions to those completed in the eligibility screening. After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep problems. After the second set of sleep assessments, the waitlist group will be offered CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These follow-up assessments will involve repeating both the sleep assessments and the clinical interview performed after the 8-week intervention.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Post-Traumatic Stress Disorder
Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)
  • Experimental: Participants will receive an 8-week course of cognitive behavioral therapy for insomnia.
  • No Intervention: Participants will be placed on a waitlist for 8 weeks.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
51
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic PTSD for at least 3 months
  • Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
  • Persistent residual insomnia

Exclusion Criteria:

  • Conditions or substances that may be associated with comorbid insomnia independent of PTSD
Both
18 Years to 65 Years
No
Contact: Aric Jensen sleepstudy@ncire.org
Contact: Maryann Lenoci 415-750-6624
United States
 
NCT00881647
Thomas C. Neylan, MD, Principal Investigator, University of California, San Francisco/VA Medical Center, San Francisco
R34 MH077667, DATR AD-TS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Thomas C. Neylan, MD University of California, San Francisco/VA Medical Center, San Francisco
National Institute of Mental Health (NIMH)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP