Seasonal Affective DisorderNCT03691792
Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy
A study testing Cognitive-Behavioral Therapy (CBT-SAD) and Light Therapy in people with Seasonal Affective Disorder, run by University of Vermont at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Cognitive-Behavioral Therapy (CBT-SAD) and Light Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont, Psychology Department
Burlington, Vermont, 05405-0134
About this study
Official title: Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy: Confirming the Targets, Mechanisms, and Treatment Sequence
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.
Read the 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.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Cognitive-Behavioral Therapy (CBT-SAD), Light Therapy
- Keywords
- cognitive-behavioral therapy, light therapy, biomarkers, treatment mechanisms
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT-SAD)Behavioural
Also called CBT-SAD
12 group sessions over 6 weeks
Light TherapyOther
10,000-lux initiated at 30 min upon waking and adjusted per treatment algorithm, continuing for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT-SAD) | Experimental | 12 1.5-hour group sessions at a rate of 2 sessions per week over 8 weeks. Receives: 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. Receives: Other: Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Semi-structured interview of depressive symptoms
Measured: past 1 week
Beck Depression Inventory-Second Edition (BDI-II)
self-report measure of depressive symptoms
Measured: past 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Sep 2018
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- head-to-head RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Kelly Rohan, University of Vermont
- Investigators
- Kelly J Rohan, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691792
- Sponsor's protocol ID
- R01MH112819
- Status last verified
- Jun 2024
- First submitted
- 28 Sep 2018
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be provided to the NIMH Data Archive
Publications
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.
PubMed 35550645
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy: Confirming the Targets, Mechanisms, and Treatment Sequence
- ClinicalTrials.gov ID
- NCT03691792
- Acronym / sponsor ID
- R01MH112819
- Conditions
- Seasonal Affective Disorder
- Keywords
- cognitive-behavioral therapy, light therapy, biomarkers, treatment mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Maryland, Baltimore
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- head-to-head RCT
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT-SAD) | Experimental | Behavioral: Cognitive-Behavioral Therapy (CBT-SAD)12 1.5-hour group sessions at a rate of 2 sessions per week over 8 weeks. |
| Light Therapy | Active comparator | Other: Light Therapy6 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT-SAD)Also: CBT-SAD12 group sessions over 6 weeks | Behavioural | Cognitive-Behavioral Therapy (CBT-SAD) |
| Light Therapy10,000-lux initiated at 30 min upon waking and adjusted per treatment algorithm, continuing for 6 weeks | Other | Light Therapy |
Primary outcome
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Time frame: past 1 week
Semi-structured interview of depressive symptoms
Beck Depression Inventory-Second Edition (BDI-II)
Time frame: past 2 weeks
self-report measure of depressive symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 35550645Rohan 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.
- Individual participant dataSharing planned: Yes. Study data will be provided to the NIMH Data Archive
Related trials for Seasonal Affective Disorder
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Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders
Major Depressive Episode
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Virtual Reality Digital Therapeutics for Seasonal Affective Disorder
Seasonal Affective Disorder (SAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly J Rohan, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT-SAD) and Light Therapy in people with Seasonal Affective Disorder, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) (time frame: past 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.