Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy
Primary Purpose
Seasonal Affective Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy (CBT-SAD)
Light Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring cognitive-behavioral therapy, light therapy, biomarkers, treatment mechanisms
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Sites / Locations
- University of Vermont, Psychology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-Behavioral Therapy (CBT-SAD)
Light Therapy
Arm Description
12 1.5-hour group sessions at a rate of 2 sessions per week over 8 weeks.
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.
Outcomes
Primary Outcome Measures
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Semi-structured interview of depressive symptoms
Beck Depression Inventory-Second Edition (BDI-II)
self-report measure of depressive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT03691792
First Posted
September 28, 2018
Last Updated
May 26, 2023
Sponsor
University of Vermont
Collaborators
University of Pittsburgh, University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03691792
Brief Title
Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy
Official Title
Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy: Confirming the Targets, Mechanisms, and Treatment Sequence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
University of Pittsburgh, University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Winter seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit each spring. The central public health challenge in the management of SAD is prevention of winter depression recurrences. This application focuses on two SAD treatments that each work for some patients: light therapy (LT) and a SAD-tailored group cognitive-behavioral therapy (CBT-SAD). LT is the acute SAD treatment with the most substantial evidence to support its efficacy. Correction of circadian phase is LT's established target and mechanism. In our recently completed R01-level efficacy trial, post-treatment outcomes for CBT-SAD and LT were very similar, but CBT-SAD was associated with fewer depression recurrences over 2-year followup than LT (27.3% in CBT-SAD vs. 45.6% in LT). CBT-SAD engaged and altered a specific mechanism of action, seasonal beliefs, which improved at twice the rate during CBT-SAD compared to LT, and this improvement was associated with lower risk for recurrence following CBT-SAD. This confirmatory efficacy R01 will apply the experimental therapeutics approach to determine how each treatment works when it is effective and to identify the best candidates for each. We will ascertain whether theoretically-derived candidate biomarkers of each treatment's target and effect are prescriptive of better outcomes in that treatment vs. the other. Biomarkers of LT's target and effect include circadian phase angle difference (PAD) and the post-illumination pupil response (PIPR). Biomarkers of CBT-SAD's target and effect include pupil dilation and sustained gamma band EEG responses to seasonal words, which are hypothesized to reflect less engagement with seasonal stimuli following CBT-SAD and corroborate with the established target of seasonal beliefs. In addition to determining change mechanisms, we will test the efficacy of a "switch" decision rule upon recurrence to inform clinical decision-making in practice. We will randomize 160 adults with SAD to 6-weeks of CBT-SAD or LT in Winter 1; follow subjects in Winter 2; and, if a depression recurrence occurs, cross them over into the alternate treatment (i.e., switch from LT to CBT-SAD or CBT-SAD to LT). All subjects will be followed in Winter 3. Biomarker assessments will occur at pre-, mid-, and post-treatment in Winter 1, at Winter 2 followup (and again at mid-/post-treatment for those crossed-over), and at Winter 3 followup. Consistent with NIMH's priorities for demonstrating target engagement at the level of RDoC-relevant biomarkers, this work aims to confirm the targets and mechanisms of LT and CBT-SAD to maximize the impact of future dissemination efforts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
cognitive-behavioral therapy, light therapy, biomarkers, treatment mechanisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
head-to-head RCT
Masking
Outcomes Assessor
Masking Description
Outcomes are rated on a semi-structured interview by raters blind to treatment assignment.
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-Behavioral Therapy (CBT-SAD)
Arm Type
Experimental
Arm Description
12 1.5-hour group sessions at a rate of 2 sessions per week over 8 weeks.
Arm Title
Light Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy (CBT-SAD)
Other Intervention Name(s)
CBT-SAD
Intervention Description
12 group sessions over 6 weeks
Intervention Type
Other
Intervention Name(s)
Light Therapy
Intervention Description
10,000-lux initiated at 30 min upon waking and adjusted per treatment algorithm, continuing for 6 weeks
Primary Outcome Measure Information:
Title
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Description
Semi-structured interview of depressive symptoms
Time Frame
past 1 week
Title
Beck Depression Inventory-Second Edition (BDI-II)
Description
self-report measure of depressive symptoms
Time Frame
past 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly J Rohan, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont, Psychology Department
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405-0134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data will be provided to the NIMH Data Archive
IPD Sharing Time Frame
After publication of the study results.
IPD Sharing URL
https://data-archive.nimh.nih.gov/
Citations:
PubMed Identifier
35550645
Citation
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.
Results Reference
derived
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Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy
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