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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 16, 2004
Last Updated Date	July 28, 2006
Start Date ^†	November 2002
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00076245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Official Title ^†	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 Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^†	Seasonal Affective Disorder Depression
Intervention ^†	Behavioral: Light Therapy Behavioral: Cognitive Behavioral Therapy Behavioral: Light Therapy plus Cognitive Behavioral Therapy
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	120
Completion Date	November 2004
Primary Completion Date
Eligibility Criteria ^†	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00076245
Responsible Party
Secondary IDs ^††	DSIR AT-AS
Study Sponsor ^†	National Institute of Mental Health (NIMH)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	July 2006
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.