Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
3 other identifiers
interventional
317
1 country
13
Brief Summary
The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 13, 2020
November 1, 2020
4.1 years
June 25, 2009
November 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse/recurrence of Major Depressive Episode
Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.
3, 6, 9, 12, 15 months
Secondary Outcomes (1)
Costs made by consumption of medical care and production loss
3, 6, 9, 12, 15 months
Study Arms (3)
Mindfulness Based Cognitive Therapy
EXPERIMENTALMindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).
Combination
EXPERIMENTALMindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
Optimal Medical Care
ACTIVE COMPARATORTreatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
Interventions
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Therapeutic dose of antidepressant medication
Eligibility Criteria
You may qualify if:
- Recurrent Major Depressive Episode (at least 3 previous episodes)
- Treatment with therapeutic dose of antidepressant medication during past six months
- Currently in full or partial remission
You may not qualify if:
- Bipolar disorder (current and previous (hypo)manic episodes)
- Psychotic disorder (current and previous)
- Neurological or somatic illness affecting depression or outcome measures
- Current alcohol or drugs dependency
- Use of high dosage benzodiazepines (\> 2 mg Lorazepam equivalents daily)
- Recent Electro Convulsive Therapy (\< 3 months ago)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pro Persona
Arnhem, Gelderland, 6800, Netherlands
Pro Persona
Ede, Gelderland, Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525 GC, Netherlands
Pro Persona
Tiel, Gelderland, Netherlands
GGZ Noord-Holland-Noord
Alkmaar, North Holland, Netherlands
Free University Medical Center and GGZ In Geest
Amsterdam, North Holland, 1000, Netherlands
AMC Amsterdam
Amsterdam, North Holland, 1100 DD, Netherlands
GGZ Rivierduinen - Leiden
Leiden, South Holland, 2300 AT, Netherlands
Leiden University Medical Center
Leiden, South Holland, 2300 RC, Netherlands
PsyQ
The Hague, South Holland, 2500, Netherlands
Parnassia ACO Zuid
The Hague, South Holland, Netherlands
GGZ Centraal
Amersfoort, Utrecht, 3800, Netherlands
GGZ Duin- en Bollenstreek
Katwijk, Netherlands
Related Publications (7)
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 Dec;76(6):966-78. doi: 10.1037/a0013786.
PMID: 19045965BACKGROUNDMa SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
PMID: 14756612BACKGROUNDTeasdale 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 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PMID: 10965637BACKGROUNDHuijbers MJ, Wentink C, Simons E, Spijker J, Speckens A. Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers. BMJ Open. 2020 Nov 11;10(11):e039053. doi: 10.1136/bmjopen-2020-039053.
PMID: 33177138DERIVEDHuijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Rogier A, Donders T, Speckens AE. Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial. Br J Psychiatry. 2016 Apr;208(4):366-73. doi: 10.1192/bjp.bp.115.168971. Epub 2016 Feb 18.
PMID: 26892847DERIVEDHuijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Donders AR, Speckens AE. Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial. J Affect Disord. 2015 Nov 15;187:54-61. doi: 10.1016/j.jad.2015.08.023. Epub 2015 Aug 18.
PMID: 26318271DERIVEDHuijbers MJ, Spijker J, Donders AR, van Schaik DJ, van Oppen P, Ruhe HG, Blom MB, Nolen WA, Ormel J, van der Wilt GJ, Kuyken W, Spinhoven P, Speckens AE. Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study. BMC Psychiatry. 2012 Aug 27;12:125. doi: 10.1186/1471-244X-12-125.
PMID: 22925198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne EM Speckens, Prof. dr.
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Anne E.M. Speckens
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 13, 2020
Record last verified: 2020-11