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Completed

NCT Number: NCT00928980

Mindfulness Based Cognitive Therapy and Antidepressant Medication in 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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pro Persona, Arnhem, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Optimal Medical Care

Drug

Therapeutic dose of antidepressant medication

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2009
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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