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Mindfulness Based Cognitive Therapy for Recurrent Depression

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ClinicalTrials.gov Identifier: NCT01038765
Recruitment Status : Unknown
Verified December 2009 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment
Depressive Disorder, Major Behavioral: Mindfulness Based Cognitive Therapy

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:

  1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
  2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
  3. 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
Study Start Date : January 2005
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : January 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Relapse/Recurrence of Major Depressive Episode [ Time Frame: 6, 9, 12, 15 months ]

Secondary Outcome Measures :
  1. Psychiatric symptoms and mindfulness skills measured by questionnaires [ Time Frame: 0, 3, 6, 9, 12, 15 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: Fonds Psychische Gezondheid, Netherlands (previously: NFGV) )
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009

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