Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy

NCT03691792 | Completed DMC

• 1 other identifier: R01MH112819
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression that affects 5% of the population (14.5 million Americans), involving substantial depressive symptoms for about 5 months of each year during most years, beginning in young adulthood.

Conditions

Seasonal Affective Disorder

Keywords

cognitive-behavioral therapy; light therapy; biomarkers; treatment mechanisms

Outcome Measures

Primary Outcomes (2)

• Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)

  Semi-structured interview of depressive symptoms

  past 1 week

• Beck Depression Inventory-Second Edition (BDI-II)

  self-report measure of depressive symptoms

  past 2 weeks

Study Arms (2)

Cognitive-Behavioral Therapy (CBT-SAD)

EXPERIMENTAL

12 1.5-hour group sessions at a rate of 2 sessions per week over 8 weeks.

Behavioral: Cognitive-Behavioral Therapy (CBT-SAD)

Light Therapy

ACTIVE COMPARATOR

6 weeks of daily light therapy at home, using a 10,000-lux light box beginning at 30 minutes upon waking, with dose subsequently adjusted per treatment algorithm.

Other: Light Therapy

Interventions

Cognitive-Behavioral Therapy (CBT-SAD) BEHAVIORAL

12 group sessions over 6 weeks

Also known as: CBT-SAD

Cognitive-Behavioral Therapy (CBT-SAD)

Light Therapy OTHER

10,000-lux initiated at 30 min upon waking and adjusted per treatment algorithm, continuing for 6 weeks

Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Principle DSM-5 diagnosis of Major Depression, Recurrent, with Seasonal Pattern. -Meet Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode (see below).
• No use or stable use of antidepressants (i.e., a consistent dose of the same medication maintained for \> 4 weeks with no plans to change).

You may not qualify if:

• Current or past light therapy or CBT for SAD.
• Presence of a comorbid Axis I disorder that requires immediate treatment (i.e., bipolar disorder, psychotic disorders, substance use disorder).
• Acute and serious suicidal intent.
• Planned absences of \>1 week from the area through March.
• History of conditions that are known contra-indications to LT, including conditions associated with toxicity of bright light to the retina (i.e., macular degeneration or any retinopathy).

Sponsors & Collaborators

• University of Vermont: lead
• University of Pittsburgh: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Vermont, Psychology Department

Burlington, Vermont, 05405-0134, United States

Location

Related Publications (1)

• Rohan KJ, Franzen PL, Roeckelin KA, Siegle GJ, Kolko DJ, Postolache TT, Vacek PM. Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depression. Trials. 2022 May 12;23(1):383. doi: 10.1186/s13063-022-06330-9.

  PMID: 35550645 DERIVED

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

Cognitive Behavioral Therapy; Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Kelly J Rohan, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are rated on a semi-structured interview by raters blind to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: head-to-head RCT

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: September 1, 2018
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 3, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of the study results.

Locations

US (1)