Clinical trial NCT00928980: Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Recurrent Major Depressive Disorder
Mindfulness Based Cognitive Therapy
Cost-effectiveness
Antidepressant medication
Randomized Controlled Trial
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2009-06-26
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities.

In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Relapse/recurrence of Major Depressive Episode
timeFrame: 3, 6, 9, 12, 15 months
Secondary outcomes:
measure: Costs made by consumption of medical care and production loss
timeFrame: 3, 6, 9, 12, 15 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Pro Persona
state: Gelderland
city: Ede
country: Netherlands
facility: Pro Persona
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Tiel
country: Netherlands
facility: Pro Persona
state: Gelderland
city: Alkmaar
country: Netherlands
facility: GGZ Noord-Holland-Noord
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Free University Medical Center and GGZ In Geest
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
state: North Holland
city: Amersfoort
country: Netherlands
facility: GGZ Centraal
state: Utrecht
city: Leiden
country: Netherlands
facility: GGZ Rivierduinen - Leiden
state: Zuid Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
city: Den Haag
country: Netherlands
facility: PsyQ
state: Zuid-Holland
city: Den Haag
country: Netherlands
facility: Parnassia ACO Zuid
state: Zuid-Holland
city: Katwijk
country: Netherlands
facility: GGZ Duin- en Bollenstreek
Study officials:
affiliation: Radboud University Medical Center
name: Anne EM Speckens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ma 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.
citation: 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 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
citation: Huijbers 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.
citation: Huijbers 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.
citation: Huijbers 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.
citation: Huijbers 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.