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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

Tracking Information
First Submitted Date  ICMJE January 16, 2004
First Posted Date  ICMJE January 19, 2004
Results First Submitted Date  ICMJE February 24, 2014
Results First Posted Date  ICMJE June 25, 2014
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE November 2002
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version [ Time Frame: Post-treatment ]
    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.
  • Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) [ Time Frame: Post-treatment ]
    Dichotomous Remission Status (remitted or not) at post-treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Official Title  ICMJE Cognitive Behavioral Approaches to Seasonal Depression
Brief Summary This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."
Detailed Description

SAD is a condition in which people experience depression as a result of seasonal variations in sunlight. Although light therapy is a common treatment for SAD, a large proportion of people with SAD are resistant to this treatment. CBT is effective for nonseasonal depressive disorders, but its use for SAD has not been thoroughly explored. This study will determine whether CBT, alone and combined with light therapy, is as effective as light therapy alone in reducing SAD symptoms.

Participants in this study will be randomly assigned to light therapy, CBT, a combination of light therapy and CBT, or a control group (no therapy) for 6 weeks. CBT will be conducted twice a week; light therapy will be conducted twice a day. Assessments will be made before, during, and after the study treatment. Depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. A 6-month and 1-year follow-up visit will also be conducted. During the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Seasonal Affective Disorder
  • Depression
Intervention  ICMJE
  • Behavioral: Light Therapy
    Light therapy will involve exposure to bright light twice a day.
  • Behavioral: Cognitive behavioral therapy (CBT)
    CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Study Arms  ICMJE
  • Experimental: 1 Light therapy
    Intervention: Behavioral: Light Therapy
  • Experimental: 2 Cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
  • Experimental: 3 Light therapy plus cognitive behavioral therapy
    Interventions:
    • Behavioral: Light Therapy
    • Behavioral: Cognitive behavioral therapy (CBT)
  • No Intervention: 4 Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2014)
61
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
120
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of seasonal affective disorder (SAD)
  • Willing and able to participate in the study procedures

Exclusion Criteria:

  • Major psychological diagnoses other than SAD
  • Current psychological or psychiatric treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00076245
Other Study ID Numbers  ICMJE R03MH065946( U.S. NIH Grant/Contract )
R03MH065946 ( U.S. NIH Grant/Contract )
DSIR AT-AS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Study Sponsor  ICMJE National Institute of Mental Health (NIMH)
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Kelly J. Rohan, PhD Uniformed Services University of the Health Sciences (USUHS)
PRS Account Henry M. Jackson Foundation for the Advancement of Military Medicine
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP