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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00881647
First received: April 14, 2009
Last updated: February 20, 2014
Last verified: February 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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
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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  
Number of Participants  
[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  
Using psychotropic medication  
[units: participants]
     
Using psychotropic medication     11     7     18  
Not using psychotropic medication     18     9     27  
[1] Depression symptoms were assessed using the Beck Depression Inventory



  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


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00881647     History of Changes
Other Study ID Numbers: R34 MH077667, R34MH077667, DATR AD-TS
Study First Received: April 14, 2009
Results First Received: January 7, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board