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

Recurrent Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259506
• Other study ID #: 2005/195
• Status: Completed
• Phase: N/A
• First received: November 28, 2005
• Last updated: June 2, 2009
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Depression

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy (MBCT)

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Ministry of the Flemish Community

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility to implement MBCT in a Flemish region
Primary	Relapse/recurrence of depression after approximately 12 months
Secondary	Health status
Secondary	Quality of life
Secondary	Coping
Secondary	Fear
Secondary	Rumination

External Links

•   Website about this trial
•   Website University Hospital Ghent