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Completed

NCT Number: NCT00259506

Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial

Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

This trial is based on the following publications:

Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse / recurrence in major depression by Mindfulness-Based Cognitive Therapy. Journal of Consulting and Clinical Psychology 2000; 68(4): 615-623.

Ma SH, Teasdale JD. Mindfulness-Based Cognitive Therapy for depression: replication and exploration of differential relapse prevention effects. Journal of Consulting and Clinical Psychology 2004; 72(1): 31-40.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 years and above
  • place of residence in accordance with a well-defined region (pilot study)
  • given informed consent
  • diagnosis of recurrent depression (DSM-IV-TR)
  • at least 3 depressive episodes in the anamnesis (depression: either primary or secondary diagnosis)
  • last depressive episode at least 8 weeks ago (DSM-IV-TR)
  • absence of a present depressive episode
  • history of treatment by an antidepressant medication
  • HRSD-score <14 at baseline assessment (Hamilton Rating Scale for Depression, HRSD-17)
  • absence of exclusion criteria

Exclusion criteria

  • based on DSM-IV-TR: current diagnosis of any of the following psychiatric disorders: lifetime mood disorder, chronic depression, dysthymia, current substance abuse, obsessive-compulsive disorder, bipolar disorder, acute psychosis, cognitive disorder, organic mental disorder, pervasive developmental disorder, mental retardation, primary diagnosis of axis-II-disorder, at risk for suicide
  • Extended experience with zen- or vipassana meditation (or mindfulness) in the past or
  • more than 1 hour practice of zen- or vipassana meditation (or mindfulness) per week during the last 8 weeks
  • other meditation practices except for MBCT during the training
  • more than 1 psychiatric consultation per 3-4 weeks during the training and follow-up
  • intensive psychotherapy during the training and follow-up
  • schizophrenia or schizoaffective disorder in the anamnesis
  • physical problems which make it difficult to participate in the programme

Treatment and study plan

Mindfulness-based cognitive therapy (MBCT)

Behavioral

Primary outcomes

  1. Feasibility to implement MBCT in a Flemish region

  2. Relapse/recurrence of depression after approximately 12 months

Secondary outcomes

  1. Health status

  2. Quality of life

  3. Coping

  4. Fear

  5. Rumination

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Ministry of the Flemish Community

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 29, 2005
Registry last updated
Jun 3, 2009

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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