Mindfulness Based Cognitive Therapy for Recurrent Depression

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Radboud University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Fonds Psychische Gezondheid

Information provided by:

Radboud University

ClinicalTrials.gov Identifier:

NCT01038765

First received: December 22, 2009

Last updated: December 23, 2009

Last verified: December 2009

History of Changes

Purpose

The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Condition	Intervention
Depressive Disorder, Major	Behavioral: Mindfulness Based Cognitive Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Relapse/Recurrence of Major Depressive Episode [ Time Frame: 6, 9, 12, 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychiatric symptoms and mindfulness skills measured by questionnaires [ Time Frame: 0, 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ]

Enrollment:	338
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy	Behavioral: Mindfulness Based Cognitive Therapy 8-weeks group based intervention of mindfulness and cognitive behavioural techniques Other Name: MBCT
No Intervention: Waiting list control group 3-month waiting list group

Detailed Description:

Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.

Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.

Study aims are:

to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment

In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

3 or more previous depressive episodes
if treated with medication: constant dose of at least 6 weeks

Exclusion Criteria:

Bipolar Disorder
Psychotic disorder
Neurological or somatic illness affecting depression or outcome measures
Current alcohol or drugs dependency
Acute need of psychiatric treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038765

Locations

Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GC

Sponsors and Collaborators

Radboud University

Fonds Psychische Gezondheid

Investigators

Principal Investigator:

Anne EM Speckens, Prof. dr.

Radboud University

More Information

Publications:

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.

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.

Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. Epub 2009 Feb 5.

Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. Epub 2006 Jun 23.

Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. Epub 2011 Oct 3.

Responsible Party:	Anne E.M. Speckens, Prof. dr., Radboud University Medical Centre
ClinicalTrials.gov Identifier:	NCT01038765 History of Changes
Other Study ID Numbers:	MFN-2005-2010, 2005 6028
Study First Received:	December 22, 2009
Last Updated:	December 23, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

Recurrent Major Depressive Disorder
Mindfulness Based Cognitive Therapy
Randomized Controlled Trial

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major

Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

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