CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
Cognitive-Behavioral Therapy (CBT) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01714050
NCT01714050N/ACompleted

Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence

University of Vermont·interventional·Posted Oct 25, 2012·Updated May 9, 2023

In Brief

A clinical study evaluating Cognitive-Behavioral Therapy (CBT) and Light Therapy (LT) for Seasonal Affective Disorder (SAD) and 2 related conditions. Completed, enrolled 177 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2012
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.7 years ago

Interventions

Cognitive-Behavioral Therapy (CBT)behavioral

Light Therapy (LT)device

SunRay (SunBox Company, Gaithersburg, MD)