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
  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:


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:

  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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
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 August 18, 2014