search
Back to results

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

Primary Purpose

Seasonal Affective Disorder, Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Light Therapy
Cognitive behavioral therapy (CBT)
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring Phototherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uniformed Services University of the Health Sciences (USUHS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1 Light therapy

2 Cognitive behavioral therapy

3 Light therapy plus cognitive behavioral therapy

4 Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2004
Last Updated
June 24, 2014
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00076245
Brief Title
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Official Title
Cognitive Behavioral Approaches to Seasonal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder, Depression
Keywords
Phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Light therapy
Arm Type
Experimental
Arm Title
2 Cognitive behavioral therapy
Arm Type
Experimental
Arm Title
3 Light therapy plus cognitive behavioral therapy
Arm Type
Experimental
Arm Title
4 Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Light Therapy
Intervention Description
Light therapy will involve exposure to bright light twice a day.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Primary Outcome Measure Information:
Title
Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version
Description
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.
Time Frame
Post-treatment
Title
Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
Description
Dichotomous Remission Status (remitted or not) at post-treatment
Time Frame
Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly J. Rohan, PhD
Organizational Affiliation
Uniformed Services University of the Health Sciences (USUHS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences (USUHS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814-4799
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sltbr.org
Description
Society for Light Therapy and Biological Rhythms [SLTBR]
URL
http://www.abct.org/Home/
Description
Association for Behavioral and Cognitive Therapies [ABCT]

Learn more about this trial

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

We'll reach out to this number within 24 hrs