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

Mitchell D Feldman⁴  Zindel V Segal⁵  Jude C Sullivan³  Daniel H Mathalon²  Maggie Chartier²  Kevin L Delucchi¹  Erin P Gillung¹  Stuart J Eisendrath¹ 

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

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

Others  :  1220228
DOI  :  10.1186/1472-6882-14-95

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

【 摘 要 】

Background

Major 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/Design

The 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.

Discussion

Treatment-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 registration

ClincalTrials.gov identifier: NCT01021254

【 授权许可】

   
2014 Eisendrath et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Health M (Ed): Burden of mental and behavioral disorders In Volume The WHO Report 2001: Menatl Health, New Understanding, New Hope. New Hope: WHO; 2001.
• [2]Murray CJ, Lopez AD: Evidence-based health policy–lessons from the Global Burden of Disease Study. Science 1996, 274(5288):740-743.
• [3]Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M, STAR*D Study Team: Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 2006, 354(12):1231-1242.
• [4]Greden JF: The burden of disease for treatment-resistant depression. J Clin Psychiatry 2001, 62(Suppl 16):26-31.
• [5]Fava M: Diagnosis and definition of treatment-resistant depression. Biol Psychiatry 2003, 53(8):649-659.
• [6]Quitkin FM, McGrath PJ, Stewart JW, Deliyannides D, Taylor BP, Davies CA, Klein DF: Remission rates with 3 consecutive antidepressant trials: effectiveness for depressed outpatients. J Clin Psychiatry 2005, 66(6):670-676.
• [7]Nierenberg AA, Feighner JP, Rudolph R, Cole JO, Sullivan J: Venlafaxine for treatment-resistant unipolar depression. J Clin Psychopharmacol 1994, 14(6):419-423.
• [8]Trivedi MH, Fava M, Wisniewski SR, Thase ME, Quitkin F, Warden D, Ritz L, Nierenberg AA, Lebowitz BD, Biggs MM, Luther JF, Shores-Wilson K, Rush AJ: Medication augmentation after the failure of SSRIs for depression. N Engl J Med 2006, 354(12):1243-1252.
• [9]Wang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC: Failure and delay in initial treatment contact after first onset of mental disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005, 62(6):603-613.
• [10]Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS: The epidemiology of major depressive disorder: Results From the National Comorbidity Survey Replication (NCS-R). JAMA 2003, 289(23):3095-3105.
• [11]Segal Z, Williams JM, Teasdale J: Mindfulness -based cognitive therapy for depression. New York: The Guilford press; 2002.
• [12]Kenny MA, Williams JM: Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther 2007, 45(3):617-625.
• [13]Eisendrath SJ, Delucchi K, Bitner R, Fenimore P, Smit M, McLane M: Mindfulness-based cognitive therapy for treatment-resistant depression: a pilot study. Psychother Psychosom 2008, 77(5):319-320.
• [14]Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA: Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol 2000, 68(4):615-623.
• [15]Ma SH, Teasdale JD: Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol 2004, 72(1):31-40.
• [16]Segal ZV, Kennedy S, Gemar M, Hood K, Pedersen R, Buis T: Cognitive reactivity to sad mood provocation and the prediction of depressive relapse. Arch Gen Psychiatry 2006, 63(7):749-755.
• [17]Omidi A, Mohammadkhani P, Mohammadi A, Zargar F: Comparing mindfulness based cognitive therapy and traditional cognitive behavior therapy with treatments as usual on reduction of major depressive disorder symptoms. Iran Red Crescent Med J 2013, 15(2):142-146.
• [18]Teasdale JD, Segal Z, Williams JM: How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther 1995, 33(1):25-39.
• [19]MacCoon DLA, Rosenkranz M, Davidson R: Lessons from an Active Control Condition: "McMindfulness, Shams, and the One-Fold Path. In Mind Life Summer Research Institute. New York: Garrison; 2007.
• [20]MacCoon DG, Imel ZE, Rosenkranz MA, Sheftel JG, Weng HY, Sullivan JC, Bonus KA, Stoney CM, Salomons TV, Davidson RJ, Lutz A: The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR). Behav Res Ther 2012, 50(1):3-12.
• [21]Miller L, Weissman M: Interpersonal psychotherapy delivered over the telephone to recurrent depressives, A pilot study. Depress Anxiety 2002, 16(3):114-117.
• [22]Mynors-Wallis LM, Gath DH, Day A, Baker F: Randomised controlled trial of problem solving treatment, antidepressant medication, and combined treatment for major depression in primary care. BMG 2000, 320(7226):26-30.
• [23]Baer RA: Mindfulness training as a clinical intervention: a conceptual and empirical review. Clinical Psychology: Science and Practice 2003, 10(2):125-143.
• [24]Depression Guideline Panel: Depression in primary care: volume 2, Treatment of Major Depression. Rockville, MD: US Department of Health and Human Serviced, Public Health Service, Angency for Health Care Policy and Research, AHCPR Publication No. 93–0551, April 1993; 1993.
• [25]Finucane A, Mercer SW: An exploratory mixed methods study of the acceptability and effectiveness of Mindfulness-Based Cognitive Therapy for patients with active depression and anxiety in primary care. BMC Psychiatry 2006, 6:14. BioMed Central Full Text
• [26]Kingston J, Chadwick P, Meron D, Skinner TC: A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. J Psychosom Res 2007, 62(3):297-300.
• [27]Donner A, Shoukri MM, Klar N, Bartfay E: Testing the equality of two dependent kappa statistics. Stat Med 2000, 19(3):373-387.
• [28]Hamilton M: Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967, 6(4):278-296.
• [29]First MB, Spitzer , Robert L, Gibbon M, Williams , Janet BW: Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition (SCID-I/P). Biometrics Research, New York State Psychiatric Institute 2002.
• [30]Guy W: ECDEU Assessment Manual for Psychopharmacology Revised (DHEW Publ No ADM 76–338). Rockville, MD: U.S. Dept. Health, Education and Welfare, Public Health Service, Alcohol, Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976.
• [31]Folstein MF, Folstein SE, McHugh PR: Mini-mental state, A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12(3):189-198.
• [32]Dew RE, Kramer SI, McCall WV: Adequacy of antidepressant treatment by psychiatric residents: the antidepressant treatment history form as a possible assessment tool. Acad Psychiatry 2005, 29(3):283-288.
• [33]Linn BS, Linn MW, Gurel L: Cumulative illness rating scale. J Am Geriatr Soc 1968, 16(5):622-626.
• [34]Miller MD, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, Mulsant B, Reynolds CF 3rd: Rating chronic medical illness burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale. Psychiatry Res 1992, 41(3):237-248.
• [35]Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC: The Longitudinal Interval Follow-up Evaluation, A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry 1987, 44(6):540-548.
• [36]Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB: The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 2003, 54(5):573-583.
• [37]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36), I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
• [38]Ware J Jr, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34(3):220-233.
• [39]Mundt JC, Marks IM, Shear MK, Greist JH: The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry 2002, 180:461-464.
• [40]Cohen S, Kamarck T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav 1983, 24(4):385-396.
• [41]Endicott J, Nee J, Harrison W, Blumenthal R: Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull 1993, 29(2):321-326.
• [42]Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L: Using self-report assessment methods to explore facets of mindfulness. Assessment 2006, 13(1):27-45.
• [43]Hayes SC, Strosahl K, Wilson KG, Bissett RT, Pistorello J, Toarmino D, Polusny MA, Dykstra TA, Batten SV, Bergan J, Stewart SH, Zvolensky MJ, Eifert GH, Bond FW, Forsyth JP, Karekla M, Mccurry SM: Measuring experiential avoidance: a preliminary test of a working model. Psychol Bull 2004, 54:553-578.
• [44]Nolen-Hoeksema S, Morrow J: A prospective study of depression and posttraumatic stress symptoms after a natural disaster: the 1989 Loma Prieta Earthquake. J Pers Soc Psychol 1991, 61(1):115-121.
• [45]Nolen-Hoeksema S, Parker LE, Larson J: Ruminative coping with depressed mood following loss. J Pers Soc Psychol 1994, 67(1):92-104.
• [46]Neff KD: The development and validation of a scale to measure self-compassion. Self and Identity 2003, 2(3):223-250.
• [47]Pollack MH: Comorbid anxiety and depression. J Clin Psychiatry 2005, 66(Suppl 8):22-29.
• [48]Souery D, Oswald P, Massat I, Bailer U, Bollen J, Demyttenaere K, Kasper S, Lecrubier Y, Montgomery S, Serretti A, Zohar J, Mendlewicz J: Clinical factors associated with treatment resistance in major depressive disorder: results from a European multicenter study. J Clin Psychiatry 2007, 68(7):1062-1070.
• [49]Rush AJ, Zimmerman M, Wisniewski SR, Fava M, Hollon SD, Warden D, Biggs MM, Shores-Wilson K, Shelton RC, Luther JF, Thomas B, Trivedi MH: Comorbid psychiatric disorders in depressed outpatients: demographic and clinical features. J Affect Disord 2005, 87(1):43-55.
• [50]Trivedi MH, Rush AJ, Wisniewski SR, Warden D, McKinney W, Downing M, Berman SR, Farabaugh A, Luther JF, Nierenberg AA, Callan JA, Sackeim HA: Factors associated with health-related quality of life among outpatients with major depressive disorder: a STAR*D report. J Clin Psychiatry 2006, 67(2):185-195.
• [51]Ravindran AV, Matheson K, Griffiths J, Merali Z, Anisman H: Stress, coping, uplifts, and quality of life in subtypes of depression: a conceptual frame and emerging data. J Affect Disord 2002, 71(1–3):121-130.
• [52]Bertschy G: [Resistant depression]. Rev Med Suisse 2007, 3(125):2072-2074. 2076–2077
• [53]Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB: Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci USA 2003, 100(24):14293-14296.
• [54]Borkovec T: Effects of expectancy on the outcome of systematic desensitization and implosive treatments for analogue anxiety. Behav Ther 1972, 3:29-40.
• [55]Devilly GJB, Thomas D: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000, 31(2):73-86.
• [56]Borkovec TDNS: Credibility of analogue therapy rationales. J Behav Therapy Experimental Psychiatry 1972, 3:257-260.
• [57]Segal Z, Teasdale J, Williams JM, Gemar M: The mindfulness-based cognitive therapy adherence scale: inter-rater reliability, adherence to protocol and treatment distinctiveness. Clinical Psychology and Psychotherapy 2002, 9:131-138.
• [58]Laird NM, Ware JH: Random-effects models for longitudinal data. Biometrics 1982, 38(4):963-974.
• [59]Cnaan A, Laird NM, Slasor P: Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Stat Med 1997, 16(20):2349-2380.
• [60]Little JM: Presenting statistics. Aust N Z J Surg 1987, 57(7):417-419.
• [61]Greenberg PE, Leong SA, Birnbaum HG, Robinson RL: The economic burden of depression with painful symptoms. J Clin Psychiatry 2003, 64(Suppl 7):17-23.
• [62]Quitkin FM: Placebos, drug effects, and study design: a clinician's guide. Am J Psychiatry 1999, 156(6):829-836.
• [63]Kessler RCSJ, Davis RB, Foster DF, Wilkey SA, Van Rompay MI, Eisenberg DM: The use of complementary and alternative therapies to treat anxiety and depression in the United States. Am J Psychiatry 2001, 158:289-294.