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

Depression Clinical Trial

Official title:

Cognitive Behavioral Approaches to Seasonal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076245
• Other study ID #: R03MH065946
• Secondary ID: R03MH065946DSIR
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2004
• Last updated: June 24, 2014
• Start date: November 2002
• Est. completion date: November 2005

Study information

• Verified date: June 2014
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2005
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Mood Disorders
• Seasonal Affective Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences (USUHS)	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version	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	No
Primary	Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)	Dichotomous Remission Status (remitted or not) at post-treatment	Post-treatment	No

External Links

•   Association for Behavioral and Cognitive Therapies [ABCT]
•   Society for Light Therapy and Biological Rhythms [SLTBR]