History of Changes for Study: NCT00076245
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Latest version (submitted June 24, 2014) on
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 November 17, 2005 Study Identification and Study Status
3 July 28, 2006 Recruitment Status, Study Status and Contacts/Locations
4 September 27, 2009 Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures and Sponsor/Collaborators
5 October 20, 2010 References and Study Status
6 June 24, 2014 Recruitment Status, Sponsor/Collaborators, Study Status, Study Identification, Study Design, Oversight, Results, References and Outcome Measures
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Study NCT00076245
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: MH65946-01A1
Brief Title: Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Official Title: Cognitive Behavioral Approaches to Seasonal Depression
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2004
Overall Status: Recruiting
Study Start: November 2002
Primary Completion:
Study Completion: November 2004
First Submitted: January 16, 2004
First Submitted that
Met QC Criteria:
January 16, 2004
First Posted: January 19, 2004 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Mental Health (NIMH)
Responsible Party:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Seasonal Affective Disorder
Keywords: Phototherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 120
Open or close this module Arms and Interventions
Intervention Details:
Behavioral: Light Therapy
Behavioral: Cognitive Behavioral Therapy
Behavioral: Light Therapy plus Cognitive Behavioral Therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

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
Open or close this module Contacts/Locations
Locations: United States, Maryland
Uniformed Services University of the Health Sciences (USUHS)
Bethesda, Maryland, United States, 20814-4799
Contact:Contact: Kelly J. Rohan, PhD 301-295-1482
Contact:Contact: Massac I. Aisha, BA 301-295-3241
Contact:Principal Investigator: Kelly J. Rohan, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Society for Light Therapy and Biological Rhythms [SLTBR]
Available IPD/Information:

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