Clinical trial NCT01714050: Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence
Official title: Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder (SAD)
Winter Depression
Major Depressive Disorder, Recurrent, With Seasonal Pattern
Keywords: seasonal affective disorder
winter depression
cognitive-behavioral therapy
light therapy
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-10-25
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 involving substantial depressive symptoms that adversely affect the family and workplace for about 5 months of each year during most years, beginning in young adulthood. This clinical trial is relevant to this public health challenge in seeking to develop and test a time-limited (i.e., acute treatment completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable cognitive-behavioral treatment with effects that endure beyond the cessation of acute treatment to prevent the annual recurrence of depression in SAD.

Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light therapy on depression recurrence status, symptom severity, and remission status during the next winter season (i.e., the next wholly new winter season after the initial winter of treatment completion), which we argue to be the most important time point for evaluating clinical outcomes following SAD intervention.

Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less severe symptoms, and a higher proportion of remissions than light therapy in the next winter. The study is designed to detect a clinically important difference between CBT and light therapy in depressive episode recurrences during the next winter, the primary endpoint, in an intent-to-treat analysis.

Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission status at post-treatment (treatment endpoint).

Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.

Detailed description: Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. SAD affects an estimated 5% of the U. S. population, over 14.5 million Americans. The central public health challenge in the management of SAD is prevention of winter depression recurrence. The established and best available treatment, light therapy, remits acute symptoms in 53% of SAD cases. However, long-term compliance with clinical practice guidelines recommending daily use of a light box from onset of first symptom through spontaneous springtime remission during every fall/winter season is poor. Time-limited alternative treatments with durable effects are needed to prevent the annual recurrence of these disabling symptoms. Our preliminary studies suggest that a novel, SAD-tailored cognitive-behavioral therapy (CBT) may be as efficacious as light therapy alone for acute SAD treatment and that CBT may have superior outcomes to light therapy during the next winter. During the next wholly new winter season following the initial winter of study treatment, the proportion of depression recurrences was significantly smaller in participants randomized to CBT (5.8%) or to CBT combined with light therapy (5.2%) than in participants randomized to light therapy alone (39.2%). As the next step in this programmatic line of intervention studies, the primary aim of the proposed project is to further test the efficacy of our CBT for SAD intervention against light therapy in a larger, more definitive randomized head-to-head comparison on next winter outcomes in an intent-to-treat (ITT) analysis using all randomized participants. This project is seeking to test for a clinically meaningful difference between CBT and light therapy on depression recurrence in the next winter (the primary outcome), thereby having the potential to impact clinical practice. The proposed work will go beyond our pilot studies in four ways: (1) This study will augment the generalizability of our prior pilot study data by relaxing the inclusion/exclusion criteria to allow for comorbid diagnoses and stable antidepressant medication use and by demonstrating the feasibility of training experienced community therapists to facilitate the CBT groups. (2) We will prospectively track recurrences and potential intervening variables that could affect outcome (e.g., new treatments, summer remission status) in the interim between treatment endpoint and the following winter. (3) This study includes a second annual winter followup to obtain preliminary data on the comparative effects of CBT vs. LT two winters after the initial winter of study treatment. (4) We will examine how potential modifiers influence the effects of CBT vs. LT, including demographic variables; baseline characteristics (e.g., depression severity, comorbidity, baseline medication status); and complete or incomplete summer remission status in the interim. If successful, this work will develop a novel treatment with important public health implications for winter depression prevention.

Eligibility criteria: Inclusion Criteria:

* aged 18 or older
* meet DSM-IV criteria for 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

Exclusion Criteria:

* past light therapy or cognitive-behavioral therapy for SAD
* presence of a comorbid Axis I disorder that requires immediate treatment
* acute and serious suicidal intent
* positive laboratory findings for hypothyroidism
* plans for major vacations or absences from the study area through March

Primary outcomes:
measure: Depression recurrence status on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD; Williams et al., 1992)
timeFrame: next winter followup (January or February of the next winter, approximately a year after study treatment)
Secondary outcomes:
measure: Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996)
timeFrame: baseline, mid-treatment (week 3), post-treatment (week 6), summer followup (August), next winter followup (January or February or the next winter), and the second winter followup (January or February two winters later)
measure: Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
timeFrame: baseline, weekly during treatment (weeks 1-5), post-treatment (week 6), summer followup (August), next winter followup (January or February of the next winter), second winter followup (January or February two winters later)
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont, Psychology Department
state: Vermont
Study officials:
affiliation: University of Vermont
name: Kelly J Rohan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rohan KJ, Burt KB, Camuso J, Perez J, Meyerhoff J. Applying experimental therapeutics to examine cognitive and chronological vulnerabilities as mediators of acute outcomes in cognitive-behavioral therapy and light therapy for winter depression. J Consult Clin Psychol. 2020 Aug;88(8):786-797. doi: 10.1037/ccp0000499.
citation: Rohan KJ, Meyerhoff J, Ho SY, Evans M, Postolache TT, Vacek PM. Outcomes One and Two Winters Following Cognitive-Behavioral Therapy or Light Therapy for Seasonal Affective Disorder. Am J Psychiatry. 2016 Mar 1;173(3):244-51. doi: 10.1176/appi.ajp.2015.15060773. Epub 2015 Nov 5.
citation: Rohan KJ, Mahon JN, Evans M, Ho SY, Meyerhoff J, Postolache TT, Vacek PM. Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes. Am J Psychiatry. 2015 Sep 1;172(9):862-9. doi: 10.1176/appi.ajp.2015.14101293. Epub 2015 Apr 10.
citation: Rohan KJ, Evans M, Mahon JN, Sitnikov L, Ho SY, Nillni YI, Postolache TT, Vacek PM. Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial. Trials. 2013 Mar 21;14:82. doi: 10.1186/1745-6215-14-82.