We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00076245
Recruitment Status : Completed
First Posted : January 19, 2004
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine

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)
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Hide Arm/Group Description 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.

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.

[Not Specified]
Period Title: Overall Study
Started 16 15 15 15
Completed 16 15 15 14
Not Completed 0 0 0 1
Arm/Group Title 1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control Total
Hide Arm/Group Description 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.

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.

[Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 16 15 15 15 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 15 participants 15 participants 61 participants
47.6  (9.7) 45.9  (15.5) 43.0  (12.8) 43.3  (7.7) 45.0  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 15 participants 15 participants 61 participants
Female
14
  87.5%
15
 100.0%
14
  93.3%
12
  80.0%
55
  90.2%
Male
2
  12.5%
0
   0.0%
1
   6.7%
3
  20.0%
6
   9.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 15 participants 15 participants 61 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 15 participants 15 participants 61 participants
16 15 15 15 61
1.Primary Outcome
Title Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version
Hide Description The Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.
Time Frame Post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Hide Arm/Group Description:
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.

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.

[Not Specified]
Overall Number of Participants Analyzed 16 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.6  (8.8) 13.3  (11.1) 8.3  (5.8) 22.6  (8.4)
2.Primary Outcome
Title Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
Hide Description Dichotomous Remission Status (remitted or not) at post-treatment
Time Frame Post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Hide Arm/Group Description:
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.

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.

[Not Specified]
Overall Number of Participants Analyzed 16 15 15 15
Measure Type: Number
Unit of Measure: participants
8 6 11 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Hide Arm/Group Description 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.

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.

[Not Specified]
All-Cause Mortality
1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Light Therapy 2 Cognitive Behavioral Therapy 3 Light Therapy Plus Cognitive Behavioral Therapy 4 Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Kelly J. Rohan, Ph.D.
Organization: Department of Psychology, University of Vermont
Phone: 802-656-0798
EMail: kelly.rohan@uvm.edu
Layout table for additonal information
Responsible Party: Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT00076245    
Other Study ID Numbers: R03MH065946 ( U.S. NIH Grant/Contract )
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