Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial

Trials

Pamela M Vacek³  Teodor T Postolache¹  Yael I Nillni²  Sheau-Yan Ho²  Lilya Sitnikov²  Jennifer N Mahon²  Maggie Evans²  Kelly J Rohan² 

[1] Mood and Anxiety Program, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA;Department of Psychology, University of Vermont, John Dewey Hall, 2 Colchester Avenue, Burlington, VT, 05405-0134, USA;Department of Medical Biostatistics, University of Vermont College of Medicine, Burlington, VT, USA

关键词: Prevention;    Depression recurrence;    Light therapy;    Cognitive-behavioral therapy;    Clinical trial;    Seasonal affective disorder;   

Others  :  1094481
DOI  :  10.1186/1745-6215-14-82

 received in 2012-10-31, accepted in 2013-03-08,  发布年份 2013

【 摘 要 】

Background

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. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD.

Methods/design

This is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes.

Discussion

The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT’s outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome.

Trial registration

Clinicaltrials.gov identifier NCT01714050

【 授权许可】

   
2013 Rohan et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Rosenthal NE, Sack DA, Gillin C: Seasonal affective disorder: A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry 1984, 41:72-80.
• [2]Booker JM, Hellekson CJ: Prevalence of seasonal affective disorder in Alaska. Am J Psychiatry 1992, 149:1176-1182.
• [3]Rosen LN, Targum SD, Terman M: Prevalence of seasonal affective disorder at four latitudes. Psychiatry Res 1990, 31:131-144.
• [4]Magnusson A, Boivin D: Seasonal affective disorder: An overview. Chronobiol Int 2003, 20:189-208.
• [5]Schlager D, Froom J, Jaffe A: Winter depression and functional impairment among ambulatory primary care patients. Compr Psychiatry 1995, 36:18-24.
• [6]Modell JG, Rosenthal NE, Harriett AE: Seasonal affective disorder and its prevention by anticipatory treatment with Buproprion XL. Biol Psychiatry 2005, 58:658-667.
• [7]Lam RW, Levitt AJ: Clinical guidelines for the treatment of seasonal affective disorder. Vancouver: Clinical and Academic Publishing; 1999.
• [8]Golden RN, Gaynes BN, Ekstrom RD: The efficacy of light therapy in the treatment of mood disorders: A meta-analysis of the evidence. Am J Psychiatry 2005, 162:656-662.
• [9]Terman M, Terman JS, Quitkin F: Light therapy for seasonal affective disorder: A review of efficacy. Neuropsychopharmacology 1989, 2:1-22.
• [10]Schwartz PJ, Brown C, Wehr TA: Winter seasonal affective disorder: A follow-up study of the first 59 patients of the National Institute of Mental Health Seasonal Studies Program. Am J Psychiatry 1996, 153:1028-1036.
• [11]Rohan KJ, Roecklein KA, Lacy TJ: Winter depression recurrence one year after cognitive-behavioral therapy, light therapy, or combination treatment. Behav Ther 2009, 40:225-238.
• [12]Beck AT, Rush JA, Shaw BF: Cognitive therapy of depression. New York: Guilford Press; 1979.
• [13]Gloaguen V, Cottrau J, Cucherat M: A meta-analysis of the effects of cognitive therapy in depressed patients. J Affect Disord 1998, 49:59-72.
• [14]Hollon SD, Stewart MO, Strunk D: Enduring effects for cognitive behavior therapy in the treatment of depression and anxiety. Annu Rev Psychol 2006, 57:285-315.
• [15]Blackburn IM, Eunson KM, Bishop S: A two-year naturalistic follow-up of depressed patients treated with cognitive therapy, pharmacotherapy and a combination of both. J Affect Disord 1986, 10:67-75.
• [16]Hollon SD, DeRubeis RJ, Shelton RC: Prevention of relapse following cognitive therapy vs medications in moderate to severe depression. Arch Gen Psychiatry 2005, 62:417-422.
• [17]Evans MD, Hollon SD, DeRubeis RJ: Differential relapse following cognitive therapy and pharmacotherapy for depression. Arch Gen Psychiatry 1992, 49:802-808.
• [18]Simons AD, Murphy GE, Levine JL: Cognitive therapy and pharmacotherapy for depression: Sustained improvement over one year. Arch Gen Psychiatry 1986, 43:43-38.
• [19]Rohan KJ, Roecklein KA, Haaga DAF: Biological and psychological mechanisms of seasonal affective disorder: A review and integration. Curr Psychiatry Rev 2009, 5:37-47.
• [20]Boland RJ, Keller MB: Course and outcome in depression. In Handbook of depression. 2nd edition. Edited by Boland RJ, Keller MB. New York: Guillford Press; 2009.
• [21]Rohan KJ, Tierney Lindsey K, Roecklein KA: Cognitive-behavioral therapy, light therapy, and their combination in treating seasonal affective disorder. J Affect Disord 2004, 80:273-283.
• [22]Rohan KJ, Roecklein KA, Tierney Lindsey K: A randomized controlled trial of cognitive-behavioral therapy, light therapy, and their combination for seasonal affective disorder. J Consult Clin Psychol 2007, 75:489-500.
• [23]Thompson C: Light therapy in the treatment of seasonal and non-seasonal affective disorders: a meta-analysis of randomised controlled trials. In Seasonal affective Disorder. Practice and Research. Edited by Partonen T, Magnusson A. Oxford: Oxford University Press; 2001:149-58.
• [24]Lewy AJ, Bauer VK, Cutler NL: Morning vs. evening light treatment of patients with winter depression. Arch Gen Psychiatry 1998, 55:890-896.
• [25]Terman M, Terman JS, Ross DC: A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry 1998, 55:875-882.
• [26]Terman JS, Terman M, Lo ES: Circadian time of morning light administration and therapeutic response in winter depression. Arch Gen Psychiatry 2001, 58:69-75.
• [27]Khalsa SB, Jewett ME, Cajochen C: A phase response curve to single bright light pulses in human subjects. J Physiol 2003, 549(3):945-952.
• [28]Eastman CI, Young MA, Fogg LF: Bright light treatment for winter depression: A placebo-controlled trial. Arch Gen Psychiatry 1998, 55:883-889.
• [29]Burgess HJ, Fogg LF, Young MA: Bright light therapy for winter depression–is phase advancing beneficial? Chronobiol Int 2004, 21:759-775.
• [30]Rohan KJ: Coping with the seasons: A cognitive-behavioral approach to seasonal affective disorder, therapist guide. New York: Oxford University Press; 2008.
• [31]System for Psychotherapy Ratings Project Staff: Final report: System for rating psychotherapy audiotapes. 1984. Unpublished manuscript
• [32]Hollon SD, Evans M, Elkin E: System for rating therapies for depression. Los Angeles, CA: Paper presented at the annual meeting of the American Psychiatric Association; 1984.
• [33]ystem for Psychotherapy Ratings Project Staff: Rater’s manual for the Collaborative Study for Psychotherapy Rating Scale-Form 6. Minneapolis: University of Minnesota and the St. Paul-Ramsey Medical Center; 1984. Unpublished manual
• [34]Williams JB, Link MJ, Rosenthal NE: Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD). New York: New York State Psychiatric Institute; 1992.
• [35]Terman M, Terman JS, Rafferty B: Experimental design and measures of success in the treatment of winter depression by bright light. Psychopharmacol Bull 1990, 26:505-510.
• [36]Keller MB, Lavori PW, Friedman B: The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry 1987, 44:540-548.
• [37]DeRubeis RJ, Hollon SD, Amsterdam JD: Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry 2005, 62:409-416.
• [38]Beck AT, Steer RA, Brown GK: Beck Depression Inventory. 2nd edition. San Antonio: The Psychological Corporation; 1996.
• [39]Little R, Yau L: Intent-to-treat analysis with for longitudinal studies with drop-outs. Biometrics 1996, 25:1324-1333.
• [40]Mazumdar S, Lui KS, Houck PR: Intent to treat analysis for longitudinal clinical trials: Coping with the challenge of missing values. J Psychiatr Res 1999, 33:87-95.
• [41]Schafer JL, Graham JW: Missing data: Our view of the state of the art. Psychol Methods 2002, 7:147-177.
• [42]Little RJA, Rubin DB: Statistical analysis with missing data. 2nd edition. Hoboken: John Wiley and Sons; 2002.
• [43]Schafer JL: Analysis of incomplete multivariate data. New York: Chapman and Hall; 1997.