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

June 25, 2009
November 7, 2013
May 2009
June 2013   (final data collection date for primary outcome measure)
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.
Relapse/recurrence of Major Depressive Episode [ Time Frame: 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00928980 on ClinicalTrials.gov Archive Site
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.
Costs made by consumption of medical care and production loss [ Time Frame: 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder, Major
  • 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
  • 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).
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • Experimental: Combination
    Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
    Interventions:
    • Behavioral: Mindfulness Based Cognitive Therapy
    • Drug: Optimal Medical Care
  • 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.
    Intervention: Drug: Optimal Medical Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00928980
MFN-2009-2013, 80-82310-98-09018, 2008/242
No
Anne Speckens, Radboud University
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Anne EM Speckens, Prof. dr. Radboud University
Radboud University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP