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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Recurrent Depression

Treatments

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Study type

Interventional

Funder types

Other

Identifiers

NCT00259506
2005/195

Details and patient eligibility

About

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

Full description

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.

Enrollment

405 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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