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Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00928980
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Anne Speckens, Radboud University

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Behavioral: Mindfulness Based Cognitive Therapy Drug: Optimal Medical Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: 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).
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Experimental: Combination
Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Drug: Optimal Medical Care
Therapeutic dose of antidepressant medication

Active Comparator: Optimal Medical Care
Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
Drug: Optimal Medical Care
Therapeutic dose of antidepressant medication




Primary Outcome Measures :
  1. Relapse/recurrence of Major Depressive Episode [ Time Frame: 3, 6, 9, 12, 15 months ]
    Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.


Secondary Outcome Measures :
  1. Costs made by consumption of medical care and production loss [ Time Frame: 3, 6, 9, 12, 15 months ]
    Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT00928980


Locations
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Netherlands
Pro Persona
Arnhem, Gelderland, Netherlands, 6800
Pro Persona
Ede, Gelderland, Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GC
Pro Persona
Tiel, Gelderland, Netherlands
GGZ Noord-Holland-Noord
Alkmaar, Noord-Holland, Netherlands
Free University Medical Center and GGZ In Geest
Amsterdam, Noord-Holland, Netherlands, 1000
AMC Amsterdam
Amsterdam, North Holland, Netherlands, 1100 DD
GGZ Centraal
Amersfoort, Utrecht, Netherlands, 3800
GGZ Rivierduinen - Leiden
Leiden, Zuid Holland, Netherlands, 2300 AT
Leiden University Medical Center
Leiden, Zuid Holland, Netherlands, 2300 RC
PsyQ
Den Haag, Zuid-Holland, Netherlands, 2500
Parnassia ACO Zuid
Den Haag, Zuid-Holland, Netherlands
GGZ Duin- en Bollenstreek
Katwijk, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Anne EM Speckens, Prof. dr. Radboud University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Speckens, Prof. dr. Anne E.M. Speckens, Radboud University
ClinicalTrials.gov Identifier: NCT00928980    
Other Study ID Numbers: MFN-2009-2013
80-82310-98-09018
2008/242
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Keywords provided by Anne Speckens, Radboud University:
Recurrent Major Depressive Disorder
Mindfulness Based Cognitive Therapy
Cost-effectiveness
Antidepressant medication
Randomized Controlled Trial
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders