CBT and Light Therapy for Seasonal Affective Disorder

Overseen By Kelly J Rohan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Antidepressants

Disqualifiers: Bipolar, Psychotic disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for Seasonal Affective Disorder (SAD), a type of depression occurring in the winter months. The study compares Cognitive-Behavioral Therapy (CBT) and Light Therapy to determine which better manages SAD symptoms. Participants may attend group therapy sessions or use a special light box at home. Ideal candidates experience recurring major depression that worsens in winter and have not previously used light therapy or CBT for SAD. Participants either do not take antidepressants or have maintained a stable dose for over four weeks. As an unphased trial, this study allows participants to contribute to understanding effective treatments for SAD.

Will I have to stop taking my current medications?

You can continue taking your current antidepressants if you have been on a stable dose for more than 4 weeks and have no plans to change it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive-Behavioral Therapy for Seasonal Affective Disorder (CBT-SAD) and light therapy are treatments that people generally handle well. Studies have found that CBT-SAD effectively reduces depression symptoms in those with seasonal affective disorder. In fact, CBT has been shown to maintain improvements better than light therapy over time.

Light therapy also shows promise. It involves using a special light box to help boost mood. A review of several studies found that bright light therapy helps reduce depression symptoms, indicating it is usually safe and effective for many people.

Both treatments have been used with many patients and have good safety records. For those considering joining a trial for these therapies, research suggests they are generally well-tolerated with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Seasonal Affective Disorder (SAD) because they offer new and potentially more effective approaches than traditional options like antidepressants and standard light therapy alone. Cognitive-Behavioral Therapy tailored for SAD (CBT-SAD) goes beyond symptom management by addressing the underlying thought patterns and behaviors that contribute to SAD, offering a more holistic approach. Meanwhile, the light therapy arm employs a structured, home-based regimen with customizable exposure adjustments, which might enhance its effectiveness and convenience compared to typical routines. Together, these treatments aim to provide more comprehensive and potentially quicker relief for those suffering from SAD.

What evidence suggests that CBT and Light Therapy could be effective for treating Seasonal Affective Disorder?

This trial will compare Cognitive-Behavioral Therapy for Seasonal Affective Disorder (CBT-SAD) and light therapy (LT) as separate treatment arms. Research has shown that both CBT-SAD and LT effectively treat this condition. Studies have found that these treatments work equally well during a SAD episode. Participants in the CBT-SAD arm may experience better long-term benefits, with fewer symptoms returning in the years after treatment. Meanwhile, those in the light therapy arm will use bright light to help reset the body's internal clock, which can reduce depressive symptoms. Overall, both treatments are strong options for managing SAD, with evidence supporting their effectiveness during treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Kelly J Rohan, Ph.D.

Principal Investigator

University of Vermont

Are You a Good Fit for This Trial?

This trial is for adults with major depression that follows a seasonal pattern, known as Winter SAD. Participants should have consistent symptoms each year and not be on changing doses of antidepressants. It's not for those who've had light therapy or CBT for SAD before, have other urgent mental health issues, are at high risk of suicide, will be away during the study period, or have eye conditions affected by bright light.

Inclusion Criteria

I have been diagnosed with seasonal depression that comes back.

I have been on a stable dose of antidepressants for over 4 weeks with no changes planned.

Meet Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode

Exclusion Criteria

Presence of a comorbid Axis I disorder that requires immediate treatment (i.e., bipolar disorder, psychotic disorders, substance use disorder)

I have undergone light therapy or cognitive behavioral therapy for seasonal affective disorder.

Acute and serious suicidal intent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT-SAD or Light Therapy. CBT-SAD involves 12 group sessions over 8 weeks, while Light Therapy involves daily sessions for 6 weeks.

6-8 weeks

12 visits (in-person) for CBT-SAD; daily home sessions for Light Therapy

Follow-up

Participants are monitored for depression recurrence and biomarker assessments in Winter 2 and Winter 3.

2 years

Follow-up visits in Winter 2 and Winter 3

Switch Treatment (if needed)

Participants experiencing depression recurrence are switched to the alternate treatment.

As needed

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy (CBT-SAD)
• Light Therapy

Trial Overview The study tests Cognitive-Behavioral Therapy (CBT-SAD) against Light Therapy to see which is more effective in treating Seasonal Affective Disorder (SAD). The goal is to determine the best long-term treatment approach to reduce depressive episodes during winter months.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy (CBT-SAD) Experimental Treatment 1 Intervention

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

Group II: Light Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Maryland School of Medicine

Collaborator

Trials

5

Recruited

790+

Citations

1. cambridge.org cambridge.org/core/journals/the-cognitive-behaviour-therapist/article/cognitive-behavioural-therapy-for-seasonal-affective-disorder-a-systematic-review-and-metaanalysis/3BE2F4E82C0D68D50EC0C33A33C41E2D

Cognitive behavioural therapy for seasonal affective disorder Data on HAM-D (n studies=2; n=205) showed that CBT was effective in reducing depressive symptoms in SAD patients compared with LT at 1–2-year ...

2. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2015.14101293

Randomized Trial of Cognitive-Behavioral Therapy Versus ... CBT-SAD and light therapy are comparably effective for SAD during an acute episode, and both may be considered as treatment options.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03691792

Optimizing Long-Term Outcomes for Winter Depression ... 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26539881/

Outcomes One and Two Winters Following Cognitive ... Preliminary studies suggest better long-term outcomes following cognitive-behavioral therapy tailored for SAD (CBT-SAD) than light therapy.

5. uptodate.com uptodate.com/contents/seasonal-affective-disorder-treatment/abstract/14

Medline ® Abstract for Reference 14 of 'Seasonal affective ... CONCLUSIONS CBT-SAD and light therapy are comparably effective for SAD during an acute episode, and both may be considered as treatment options. AD: From the ...

6. nccih.nih.gov nccih.nih.gov/health/providers/digest/seasonal-affective-disorder-and-complementary-health-approaches-science

Seasonal Affective Disorder and Complementary Health ... A 2016 randomized head-to-head trial of 177 participants found that CBT-SAD was superior to light therapy two winters following acute treatment, suggesting ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032703000983

Cognitive-behavioral therapy, light therapy, and their ... Conclusions: The nearly half of SAD patients who do not remit with light alone may benefit from CBT as an adjunct or alternative treatment, especially as a ...