Clinical trial NCT00259506: Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Official title: Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Depression
Keywords: Recurrent depression
Mental Health
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Ministry of the Flemish Community
First posted: 2005-11-29
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility to implement MBCT in a Flemish region
measure: Relapse/recurrence of depression after approximately 12 months
Secondary outcomes:
measure: Health status
measure: Quality of life
measure: Coping
measure: Fear
measure: Rumination
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Kees van Heeringen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: