Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | July 2008 |
| End Date: | February 2014 |
| Contact: | Kelly J Rohan, Ph.D. |
| Email: | kelly.rohan@uvm.edu |
| Phone: | 802-656-0798 |
Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence
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.
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.
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.
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.
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
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