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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076245
First Posted: January 19, 2004
Last Update Posted: June 25, 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):
Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
Results First Submitted: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   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 
Overall Participants Analyzed 
[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



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: R03MH065946 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Submitted: January 16, 2004
First Posted: January 19, 2004
Results First Submitted: February 24, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014