Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study
1 Department of Psychiatry, Radboud University Nijmegen Medical Center, Reinier Postlaan 10, Nijmegen 6525 GC, The Netherlands
2 Pro Persona Ede, Willy Brandtlaan 20, Ede 6716 RR, The Netherlands
3 Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Nijmegen Medical Center, Geert Grooteplein 21, Nijmegen 6525 EZ, The Netherlands
4 GGZ inGeest, partner VU University Medical Center, A.J. Ernststraat 1187, Amsterdam 1081 HL, The Netherlands
5 Department of Psychiatry, Academic Medical Center, University of Amsterdam, Meibergdreef 5, Amsterdam 1105 AZ, The Netherlands
6 Parnassia Bavo Psychiatric Institute, Lijnbaan 4, The Hague, 2512 VA, The Netherlands
7 Department of Psychiatry, University Medical Center Groningen, Groningen University, Hanzeplein 1, Groningen, 9713 GZ, The Netherlands
8 Mood Disorders Centre, School of Psychology, University of Exeter, The Queen's Drive Exeter, Devon, EX4 4QJ, UK
9 Institute of Psychology, Leiden University, Wassenaarseweg 52, AK Leiden 2333, The Netherlands
BMC Psychiatry 2012, 12:125 doi:10.1186/1471-244X-12-125Published: 27 August 2012
Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT?
Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio.
Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT.