Implementation and Evaluation of "Mindfulness-Based Cogni... | NCT00259506

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2009

Last Update Posted Date

Jun 3, 2009Estimated

Name	Class
Ministry of the Flemish Community	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

405Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Cognitive Therapy (MBCT)	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Measure	Description	Time Frame
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months

Measure	Description	Time Frame
Health status
Quality of life
Coping

ID	Term
D003863	Depression
D000092862	Psychological Well-Being

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010549	Personal Satisfaction

ID	Term
D064866	Mindfulness
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities