Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence
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|ClinicalTrials.gov Identifier: NCT01714050|
Recruitment Status : Unknown
Verified February 2014 by Kelly Rohan, University of Vermont.
Recruitment status was: Active, not recruiting
First Posted : October 25, 2012
Last Update Posted : February 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Affective Disorder (SAD) Winter Depression Major Depressive Disorder, Recurrent, With Seasonal Pattern||Behavioral: Cognitive-Behavioral Therapy (CBT) Device: Light Therapy (LT)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
Experimental: Cognitive-Behavioral Therapy (CBT)
The CBT is a SAD-tailored version of Beck et al.'s (1979) cognitive therapy for depression called "Coping with the Seasons" (Rohan, 2008). The rationale addresses environmental changes, thoughts, and behaviors in SAD onset and maintenance. It seeks to change behaviors and thoughts to improve coping with winter. Behaviors that promote enjoyment in the winter are increased. Negative thoughts that interfere with self-esteem and negative thoughts about winter are identified and addressed. A relapse-prevention component addresses early identification of negative anticipatory thoughts about winter and SAD-related behavior changes, using the CBT skills learned to cope with subsequent winter seasons, and development of a personalized relapse-prevention plan. The CBT sessions are administered twice a week over 6 weeks (total of 12 sessions) with 4-8 participants per group. The CBT is led by one of three licensed Ph.D.-level psychologists working on the project.
Behavioral: Cognitive-Behavioral Therapy (CBT)
Experimental: Light Therapy (LT)
LT will be initiated at 30-minutes in the morning at home, first thing upon awakening, using a light box with an ultraviolet shield that emits 10,000-lux of white fluorescent light. After the first week, an M.D. light therapy consultant will recommend individually-tailored, clinical adjustments to the duration and timing of light use to maximize response and reduce any reported side effects. For each of the 6-weeks of LT, LT participants will complete a Light Therapy Side Effects Questionnaire to assess side effects attributed to LT. Participants will keep daily LT compliance diaries to record the timing and duration of LT. After the 6-weeks of monitoring, participants may choose to continue using the light box through April. We will offer LT participants who wish to use light therapy in the next fall/winter season access to our light boxes if they agree to followup with a physician or other qualified professional for monitoring and side effects management.
Device: Light Therapy (LT)
SunRay (SunBox Company, Gaithersburg, MD)
- 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) [ Time Frame: next winter followup (January or February of the next winter, approximately a year after study treatment) ]The SIGH-SAD (Williams et al., 1992), the most commonly used clinical assessment device for detecting changes in SAD symptoms in light therapy research, includes the 21-item Structured Interview Guide for the Hamilton Rating Scale for Depression (HAM-D) and a supplementary 8-item subscale to assess atypical depressive symptoms associated with SAD. The primary outcome measure is SIGH-SAD recurrence status at the next winter followup. A trained rater, blind to the treatment condition, will administer the SIGH-SAD at pre-treatment, treatment weeks 1-5, post-treatment, summer followup, next winter followup, and second winter followup. A second blinded rater will rate audiotapes of the SIGH-SADs to assess inter-rater reliability.
- Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996) [ Time Frame: 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) ]The BDI-II (Beck et al., 1996) is a 21-item measure of depressive symptom severity. The BDI-II has demonstrated good test-retest reliability and convergent validity (Beck et al., 1996). This study will use the BDI-II as a continuous measure of depressive symptom severity. Studies have also used the BDI-II to estimate remission rates subsequent to treatment (Gortner et al., 1996). Therefore, dichomotous remission status on the BDI-II will also be assessed. The BDI-II will be administered at baseline, mid-treatment (week 3) and post-treatment (week 6), summer followup, next winter followup, and the second winter followup.
- Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) [ Time Frame: 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) ]In addition to the primary outcome of SIGH-SAD depression recurrence status, other secondary measures based on the SIGH-SAD will include continuous SIGH-SAD scores and SIGH-SAD remission status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714050
|United States, Vermont|
|University of Vermont, Psychology Department|
|Burlington, Vermont, United States, 05405-0134|
|Principal Investigator:||Kelly J Rohan, Ph.D.||University of Vermont|