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Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

NCT ID: NCT00928980

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Depressive Disorder, Major

Keywords

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Recurrent Major Depressive Disorder Mindfulness Based Cognitive Therapy Cost-effectiveness Antidepressant medication Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Based Cognitive Therapy

Mindfulness 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).

Group Type EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Intervention Type BEHAVIORAL

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Combination

Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).

Group Type EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Intervention Type BEHAVIORAL

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Optimal Medical Care

Intervention Type DRUG

Therapeutic dose of antidepressant medication

Optimal Medical Care

Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.

Group Type ACTIVE_COMPARATOR

Optimal Medical Care

Intervention Type DRUG

Therapeutic dose of antidepressant medication

Interventions

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Mindfulness Based Cognitive Therapy

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Intervention Type BEHAVIORAL

Optimal Medical Care

Therapeutic dose of antidepressant medication

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anne Speckens

Prof. dr. Anne E.M. Speckens

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne EM Speckens, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Pro Persona

Arnhem, Gelderland, Netherlands

Site Status

Pro Persona

Ede, Gelderland, Netherlands

Site Status

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Pro Persona

Tiel, Gelderland, Netherlands

Site Status

GGZ Noord-Holland-Noord

Alkmaar, North Holland, Netherlands

Site Status

Free University Medical Center and GGZ In Geest

Amsterdam, North Holland, Netherlands

Site Status

AMC Amsterdam

Amsterdam, North Holland, Netherlands

Site Status

GGZ Rivierduinen - Leiden

Leiden, South Holland, Netherlands

Site Status

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

PsyQ

The Hague, South Holland, Netherlands

Site Status

Parnassia ACO Zuid

The Hague, South Holland, Netherlands

Site Status

GGZ Centraal

Amersfoort, Utrecht, Netherlands

Site Status

GGZ Duin- en Bollenstreek

Katwijk, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 19045965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14756612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10965637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33177138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26892847 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26318271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22925198 (View on PubMed)

Other Identifiers

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80-82310-98-09018

Identifier Type: -

Identifier Source: secondary_id

2008/242

Identifier Type: -

Identifier Source: secondary_id

MFN-2009-2013

Identifier Type: -

Identifier Source: org_study_id