- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00076245
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Cognitive Behavioral Approaches to Seasonal Depression
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20814-4799
- Uniformed Services University of the Health Sciences (USUHS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Light therapy
|
Light therapy will involve exposure to bright light twice a day.
|
Experimental: 2 Cognitive behavioral therapy
|
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
Experimental: 3 Light therapy plus cognitive behavioral therapy
|
Light therapy will involve exposure to bright light twice a day.
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
No Intervention: 4 Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post-treatment
|
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
|
Post-treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kelly J. Rohan, PhD, Uniformed Services University of the Health Sciences (USUHS)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03MH065946 (U.S. NIH Grant/Contract)
- DSIR AT-AS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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