NCT00076245

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2004

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

June 25, 2014

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

January 16, 2004

Results QC Date

February 24, 2014

Last Update Submit

June 24, 2014

Conditions

Keywords

Phototherapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

1 Light therapy

EXPERIMENTAL
Behavioral: Light Therapy

2 Cognitive behavioral therapy

EXPERIMENTAL
Behavioral: Cognitive behavioral therapy (CBT)

3 Light therapy plus cognitive behavioral therapy

EXPERIMENTAL
Behavioral: Light TherapyBehavioral: Cognitive behavioral therapy (CBT)

4 Control

NO INTERVENTION

Interventions

Light TherapyBEHAVIORAL

Light therapy will involve exposure to bright light twice a day.

1 Light therapy3 Light therapy plus cognitive behavioral therapy

CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.

2 Cognitive behavioral therapy3 Light therapy plus cognitive behavioral therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of seasonal affective disorder (SAD)
  • Willing and able to participate in the study procedures

You may not qualify if:

  • Major psychological diagnoses other than SAD
  • Current psychological or psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of the Health Sciences (USUHS)

Bethesda, Maryland, 20814-4799, United States

Location

Related Links

MeSH Terms

Conditions

Seasonal Affective DisorderDepression

Interventions

PhototherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Kelly J. Rohan, Ph.D.
Organization
Department of Psychology, University of Vermont

Study Officials

  • Kelly J. Rohan, PhD

    Uniformed Services University of the Health Sciences (USUHS)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2004

First Posted

January 19, 2004

Study Start

November 1, 2002

Primary Completion

February 1, 2004

Study Completion

November 1, 2005

Last Updated

June 25, 2014

Results First Posted

June 25, 2014

Record last verified: 2014-06

Locations