Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol

BMC Complementary and Alternative Medicine

Study Protocol

Zindel V Segal¹  Maggie Chartier²  Stuart J Eisendrath³  Erin P Gillung³  Kevin L Delucchi³  Daniel H Mathalon⁴  Mitchell D Feldman⁵  Jude C Sullivan⁶ 

[1] Department of Psychiatry, University of Toronto, 250 College Street, M5T1R8, Toronto, ON, USA;San Francisco VA Medical Center, 4150 Clement Street, 94121, San Francisco, CA, USA;University of California, San Francisco Department of Psychiatry, Box 0984-AIP, 401 Parnassus Avenue, 94143, San Francisco, CA, USA;University of California, San Francisco Department of Psychiatry, Box 0984-AIP, 401 Parnassus Avenue, 94143, San Francisco, CA, USA;San Francisco VA Medical Center, 4150 Clement Street, 94121, San Francisco, CA, USA;University of California, San Francisco, Division of General Internal Medicine, 1545 Divisadero Street, Suite 315, 94143-0320, San Francisco, CA, USA;University of Wisconsin, Madison Hospital & Clinics Sports Medicine Center, 621 Science Drive, 53711, Madison, WI, USA;

关键词: Depression;    Treatment-resistant;    Mindfulness;    Meditation;    MBCT;   

DOI  :  10.1186/1472-6882-14-95

 received in 2014-02-03, accepted in 2014-02-27,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundMajor depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.Methods/DesignThe purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.DiscussionTreatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants’ clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.Trial registrationClincalTrials.gov identifier: NCT01021254

【 授权许可】

CC BY   
© Eisendrath et al.; licensee BioMed Central Ltd. 2014