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Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00881647
First Posted: April 15, 2009
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Post-Traumatic Stress Disorder
Intervention: Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CBT-I 8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
Waitlist Participants placed on a waitlist for 8 weeks.

Participant Flow:   Overall Study
    CBT-I   Waitlist
STARTED   29   16 
COMPLETED   27   15 
NOT COMPLETED   2   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

Reporting Groups
  Description
CBT-I 8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
Waitlist Participants placed on a waitlist for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   CBT-I   Waitlist   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   16   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.1  (10.4)   37.3  (11.0)   37.2  (10.5) 
Gender 
[Units: Participants]
     
Female   22   9   31 
Male   7   7   14 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   1   6 
White   20   12   32 
More than one race   0   0   0 
Unknown or Not Reported   1   1   2 
Region of Enrollment 
[Units: Participants]
     
United States   29   16   45 
Marital Status 
[Units: Participants]
     
Single   20   10   30 
Married/Partnered   6   2   8 
Divorced   3   3   6 
Separated   0   1   1 
Veteran Status 
[Units: Participants]
     
Veteran   3   6   9 
Not veteran   26   10   36 
PTSD Duration 
[Units: Years]
Mean (Standard Deviation)
 20.4  (13.6)   15.0  (13.8)   18.5  (2.1) 
Current Depression [1] 
[Units: Participants]
     
Depressed   5   4   9 
Not depressed   24   12   36 
[1] Depression symptoms were assessed using the Beck Depression Inventory
Using psychotropic medication 
[Units: Participants]
     
Using psychotropic medication   11   7   18 
Not using psychotropic medication   18   9   27 


  Outcome Measures
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1.  Primary:   Sleep Latency (SL)   [ Time Frame: After 8 weeks of study participation ]

2.  Primary:   Minutes of Wake After Sleep Onset (WASO)   [ Time Frame: After 8 weeks of study participation ]

3.  Primary:   Sleep Efficiency (SE)   [ Time Frame: After 8 weeks of study participation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas C. Neylan, MD
Organization: University of California, San Francisco
phone: 415-750-6961
e-mail: thomas.neylan@ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00881647     History of Changes
Other Study ID Numbers: R34MH077667 ( U.S. NIH Grant/Contract )
DATR AD-TS
First Submitted: April 14, 2009
First Posted: April 15, 2009
Results First Submitted: January 7, 2014
Results First Posted: February 21, 2014
Last Update Posted: March 17, 2014