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Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT00076245
First received: January 16, 2004
Last updated: June 24, 2014
Last verified: June 2014
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Treatment
Conditions: Seasonal Affective Disorder
Depression
Interventions: Behavioral: Light Therapy
Behavioral: Cognitive behavioral therapy (CBT)

  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
1 Light Therapy Light Therapy: Light therapy will involve exposure to bright light twice a day.
2 Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
3 Light Therapy Plus Cognitive Behavioral Therapy

Light Therapy: Light therapy will involve exposure to bright light twice a day.

Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.

4 Control No text entered.

Participant Flow:   Overall Study
    1 Light Therapy     2 Cognitive Behavioral Therapy     3 Light Therapy Plus Cognitive Behavioral Therapy     4 Control  
STARTED     16     15     15     15  
COMPLETED     16     15     15     14  
NOT COMPLETED     0     0     0     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.
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Reporting Groups
  Description
1 Light Therapy Light Therapy: Light therapy will involve exposure to bright light twice a day.
2 Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
3 Light Therapy Plus Cognitive Behavioral Therapy

Light Therapy: Light therapy will involve exposure to bright light twice a day.

Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.

4 Control No text entered.
Total Total of all reporting groups

Baseline Measures
    1 Light Therapy     2 Cognitive Behavioral Therapy     3 Light Therapy Plus Cognitive Behavioral Therapy     4 Control     Total  
Number of Participants  
[units: participants]
  16     15     15     15     61  
Age  
[units: years]
Mean ± Standard Deviation
  47.6  ± 9.7     45.9  ± 15.5     43.0  ± 12.8     43.3  ± 7.7     45.0  ± 5.8  
Gender  
[units: participants]
         
Female     14     15     14     12     55  
Male     2     0     1     3     6  
Race/Ethnicity, Customized  
[units: participants]
         
White     13     11     12     12     48  
Asian     0     1     2     0     3  
African American     2     2     1     2     7  
Hispanic     1     0     0     1     2  
Other     0     1     0     0     1  
Region of Enrollment  
[units: participants]
         
United States     16     15     15     15     61  



  Outcome Measures
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1.  Primary:   Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version   [ Time Frame: Post-treatment ]

2.  Primary:   Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)   [ Time Frame: Post-treatment ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kelly J. Rohan, Ph.D.
Organization: Department of Psychology, University of Vermont
phone: 802-656-0798
e-mail: kelly.rohan@uvm.edu


No publications provided


Responsible Party: Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT00076245     History of Changes
Other Study ID Numbers: R03 MH65946, R03MH065946, DSIR AT-AS
Study First Received: January 16, 2004
Results First Received: February 24, 2014
Last Updated: June 24, 2014
Health Authority: United States: Federal Government