Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: The PREVENT trial

Trials

Volumn 11, Issue , 2010, Pages

  Kuyken, Willem ^a   Byford, Sarah ^b   Byng, Richard ^c   Dalgleish, Tim ^d   Lewis, Glyn ^e   Taylor, Rod ^c   Watkins, Edward R ^a   Hayes, Rachel ^a   Lanham, Paul ^f   Kessler, David ^e   Morant, Nicola ^g   Evans, Alison ^a  

^a UNIVERSITY OF EXETER   (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c PLYMOUTH UNIVERSITY PENINSULA SCHOOLS OF MEDICINE AND DENTISTRY   (United Kingdom)

^d MRC COGNITION AND BRAIN SCIENCES UNIT   (United Kingdom)

^e UNIVERSITY OF BRISTOL   (United Kingdom)

^f c/o Depression Alliance ^*  (United Kingdom)

^g UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; COGNITIVE THERAPY; COMORBIDITY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; HEALTH CARE POLICY; HUMAN; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; PROPHYLAXIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME; COST BENEFIT ANALYSIS; DRUG COST; ECONOMICS; HEALTH CARE COST; METHODOLOGY; PSYCHOLOGICAL ASPECT; TIME;

ANTIDEPRESSIVE AGENTS; CLINICAL PROTOCOLS; COGNITIVE THERAPY; COST-BENEFIT ANALYSIS; DEPRESSIVE DISORDER, MAJOR; DRUG COSTS; HEALTH CARE COSTS; HUMANS; QUALITY OF LIFE; RECURRENCE; RESEARCH DESIGN; SINGLE-BLIND METHOD; TIME FACTORS; TREATMENT OUTCOME;

EID: 77957986211     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-11-99     Document Type: Article

References (52)

1. Judd LL. The clinical course of unipolar major depressive disorders. Arch Gen Psychiatry 1997, 54:989-991.
2. Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet 2007, 370:851-858. 10.1016/S0140-6736(07)61415-9, 17826170.
3. Murray CJL, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global burden of disease study. Lancet 1997, 349:1498-1504. 10.1016/S0140-6736(96)07492-2, 9167458.
4. Layard R. Health policy - The case for psychological treatment centres. Br Med J 2006, 332:1030-1032.
5. The Kings Fund. Paying the price: The cost of mental health care in England to 2026. 2008, London, The Kings Fund, McCrone P Dhanasiri S, Patel A, Knapp M, Lawton-Smith S, The Kings Fund. ., http://www.kingsfund.org.uk/publications/paying_the_price.html
6. Frank E, Kupfer DJ, Perel JM, Cornes C, Jarrett DB, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ. 3-Year Outcomes for Maintenance Therapies in Recurrent Depression. Arch Gen Psychiatry 1990, 47:1093-1099.
7. Kupfer DJ, Frank E, Perel JM, Cornes C, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ. 5-Year Outcome for Maintenance Therapies in Recurrent Depression. Arch Gen Psychiatry 1992, 49:769-773.
8. Vos T, Haby MM, Barendregt JJ, Kruijshaar M, Corry J, Andrews G. The burden of major depression avoidable by longer-term treatment strategies. Arch Gen Psychiatry 2004, 61:1097-1103. 10.1001/archpsyc.61.11.1097, 15520357.
9. Geddes JR, Carney SM, Davies C, Furukawa TA, Kupfer DJ, Frank E, Goodwin GM. Relapse prevention with antidepressant drug treatment in depressive disorders: a systematic review. Lancet 2003, 361:653-661. 10.1016/S0140-6736(03)12599-8, 12606176.
10. Katon W, Schulberg H. Epidemiology of Depression in Primary Care. Gen Hosp Psychiatry 1992, 14:237-247. 10.1016/0163-8343(92)90094-Q, 1505745.
11. National Institute for Clinical Excellence Depression: the treatment and management of depression in adults (update). Clinical Guideline 90. 2009, National Institute for Clinical Excellence., http://guidance.nice.org.uk/CG90
12. van Schaik DJF, Klijn AF, van Hout HPJ, van Marwijk HWJ, Beekman ATF, de Haan M, van Dyck R. Patients' preferences in the treatment of depressive disorder in primary care. Gen Hosp Psychiatry 2004, 26:184-189. 10.1016/j.genhosppsych.2003.12.001, 15121346.
13. Olfson M, Marcus SC, Tedeschi M, Wan GJ. Continuity of antidepressant treatment for adults with depression in the United States. Am J Psychiatry 2006, 163:101-108. 10.1176/appi.ajp.163.1.101, 16390896.
14. Cooper C, Bebbington P, King M, Brugha T, Meltzer H, Bhugra D, Jenkins R. Why people do not take their psychotropic drugs as prescribed: results of the 2000 National Psychiatric Morbidity Survey. Acta Psychiatrica Scandinavica 2007, 116:47-53. 10.1111/j.1600-0447.2006.00974.x, 17559600.
15. Hollon SD, Munoz RF, Barlow DH, Beardslee WR, Bell CC, Bernal G, Clarke GN, Franciosi LP, Kazdin AE, Kohn L, Linehan MM, Markowitz JC, Miklowitz DJ, Persons JB, Niederehe G, Sommers D. Psychosocial intervention development for the prevention and treatment of depression: Promoting innovation and increasing access. Biological Psychiatry 2002, 52:610-630. 10.1016/S0006-3223(02)01384-7, 12361671.
16. Hirschfield RMA, Keller MB, Panico S, Arons BS, Barlow D, Davidoff F, Endicott J, Froom J, Goldstein M, Gorman JM, Marek RG, Maurer TA, Meyer R, Phillips K, Ross J, Schwenk TL, Sharfstein SS, Thase ME, Wyatt RJ. The national depressive and manic-depressive association consensus statement on the undertreatment of depression. Jama-Journal of the American Medical Association 1997, 277:333-340.
17. Segal ZV, Williams JMG, Teasdale JD. Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse 2002, New York: Guilford Press.
18. Baer RA. Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology-Science and Practice 2003, 10:125-143.
19. Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits - A meta-analysis. Journal of Psychosomatic Research 2004, 57:35-43. 10.1016/S0022-3999(03)00573-7, 15256293.
20. Kenny MA, Williams JMG. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behaviour Research and Therapy 2007, 45:617-625. 10.1016/j.brat.2006.04.008, 2808477, 16797486.
21. Kingston T, Bates A, Dooley B, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychology and Psychotherapy-Theory Research and Practice 2007, 80:193-203.
22. Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: Replication and exploration of differential relapse prevention effects. J Consult Clin Psychol 2004, 72:31-40. 10.1037/0022-006X.72.1.31, 14756612.
23. Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol 2000, 68:615-623. 10.1037/0022-006X.68.4.615, 10965637.
24. Coelho HF, Canter PH, Ernst E. Mindfulness-based cognitive therapy: Evaluating current evidence and informing future research. J Consult Clin Psychol 2007, 75:1000-1005. 10.1037/0022-006X.75.6.1000, 18085916.
25. Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-Based Cognitive Therapy to Prevent Relapse in Recurrent Depression. J Consult Clin Psychol 2008, 76:966-978. 10.1037/a0013786, 19045965.
26. Allen M, Bromley A, Kuyken W, Sonnenberg SJ. Participants' experiences of mindfulness-based cognitive therapy: "It changed me in just about every way possible". Behav Cogn Psychother 2009, 37:413-430. 10.1017/S135246580999004X, 19508744.
27. Zimmerman M, McGlinchey JB, Posternak MA, Friedman M, Attiullah N, Boerescu D. How Should Remission From Depression Be Defined? The Depressed Patient's Perspective. Am J Psychiatry 2006, 163:148-150. 10.1176/appi.ajp.163.1.148, 16390903.
28. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002, 59:877-883. 10.1001/archpsyc.59.10.877, 12365874.
29. Smith A. Clinical uses of mindfulness training for older people. Behavioural and Cognitive Psychotherapy 2004, 32:432-430.
30. White K, Holden ER, Byng R, Mullan E, Kuyken W. Under/over-recruitment to mental health trials. Acta Psychiatrica Scandinavica 2007, 116:158. 10.1111/j.1600-0447.2007.01061.x, 17650285.
31. Williams JBW, Kobak KA, Bech P, Engelhardt N, Evans K, Lipsitz J, Olin J, Pearson J, Kalali A. The GRID-HAMD: standardization of the Hamilton depression rating scale. International Clinical Psychopharmacology 2008, 23:120-129. 10.1097/YIC.0b013e3282f948f5, 18408526.
32. Donoghue JM, Tylee A. The treatment of depression: Prescribing patterns of antidepressants in primary care in the UK. Br J Psychiatry 1996, 168:164-168. 10.1192/bjp.168.2.164, 8837905.
33. Byford S, McCrone P, Barrett B. Developments in the quantity and quality of economic evaluations in mental health. Current Opinion in Psychiatry 2003, 16:703-707.
34. Morisky DE, Green LW, Levine DM. Concurrent and Predictive-Validity of A Self-Reported Measure of Medication Adherence. Med Care 1986, 24:67-74. 10.1097/00005650-198601000-00007, 3945130.
35. Kabat-Zinn J. Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation 1990, New York: Delacorte.
36. Beck AT, Rush AJ, Shaw BF, Emery G. Cognitive therapy of depression 1979, New York: Guilford Press.
37. Hollon SD, DeRubeis RJ, Shelton RC, Amsterdam JD, Salomon RM, O'Reardon JP, Lovett ML, Young PR, Haman KL, Freeman BB, Gallop R. Prevention of Relapse Following Cognitive Therapy vs Medications in Moderate to Severe Depression. Arch Gen Psychiatry 2005, 62:417-422. 10.1001/archpsyc.62.4.417, 15809409.
38. Lau MA, Segal ZV, Williams JM. Teasdale's differential activation hypothesis: implications for mechanisms of depressive relapse and suicidal behaviour. Behaviour Research and Therapy 2004, 42:1001-1017. 10.1016/j.brat.2004.03.003, 15325898.
39. Segal ZV, Teasdale JD, Williams JMG, Gemar MC. The mindfulness-based cognitive therapy adherence scale: Inter- rater reliability, adherence to protocol and treatment distinctiveness. Clinical Psychology and Psychotherapy 2002, 9:131-138.
40. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol 2010, 78:169-183. 10.1037/a0018555, 2848393, 20350028.
41. Spitzer RL, Williams JBW, Gibbon M, First MB. The Structured Clinical Interview for Dsm-III-R (SCID) .1. History, Rationale, and Description. Arch Gen Psychiatry 1992, 49:624-629.
42. Spitzer RL, Williams JBW, Gibbon M, First MB. Structured Clinical Interview for DSM-IV (SCID) 1996, Washington DC: American Psychiatric Association.
43. Williams JBW. A structured clinical interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry 1998, 45:742-747.
44. Beck AT, Steer RA, Brown GK. The Beck Depression Inventory 1996, San Antonio, TX: The Psychological Corporation, Second.
45. Brooks R. EuroQol: the current state of play. Health Policy 1996, 37:53-72. 10.1016/0168-8510(96)00822-6, 10158943.
46. EuroQol Group A new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208. 10.1016/0168-8510(90)90421-9, 10109801, EuroQol Group.
47. Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The world health organization health and work performance questionnaire (HPQ). Journal of Occupational and Environmental Medicine 2003, 45:156-174. 10.1097/01.jom.0000052967.43131.51, 12625231.
48. Koopmanschap MA, Rutten FFH, Vanineveld BM, Vanroijen L. The Friction Cost Method for Measuring Indirect Costs of Disease. Journal of Health Economics 1995, 14:171-189. 10.1016/0167-6296(94)00044-5, 10154656.
49. Kuyken W, Watkins ER, Holden ER, White K, Taylor RS, Byford S, Teasdale JD, Dalgleish T. How does mindfulness-based cognitive therapy work?. Behaviour Research and Therapy 2010, 48:1105-12. 10.1016/j.brat.2010.08.003, 20810101.
50. Efron B, Tibshirani RJ. An introduction to the bootstrap 1993, New York: Chapman Hall.
51. Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed?. Br Med J 2000, 320:1197-1200.
52. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: The role of cost-effectiveness acceptability curves. Health Economics 2001, 10:779-787. 10.1002/hec.635, 11747057.