Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Anne Speckens, Radboud University
ClinicalTrials.gov Identifier:
NCT00928980
First received: June 25, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention
Depressive Disorder, Major
Behavioral: Mindfulness Based Cognitive Therapy
Drug: Optimal Medical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Relapse/recurrence of Major Depressive Episode [ Time Frame: 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ]
    Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.


Secondary Outcome Measures:
  • Costs made by consumption of medical care and production loss [ Time Frame: 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 317
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  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: NCT00928980

Locations
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
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 Speckens, Prof. dr. Anne E.M. Speckens, Radboud University
ClinicalTrials.gov Identifier: NCT00928980     History of Changes
Other Study ID Numbers: MFN-2009-2013, 80-82310-98-09018, 2008/242
Study First Received: June 25, 2009
Last Updated: November 7, 2013
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
Cost-effectiveness
Antidepressant medication
Randomized Controlled Trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014