Recurrent DepressionNCT00259506
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
A study testing Mindfulness-Based Cognitive Therapy (MBCT) in people with Recurrent Depression, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Depression
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 405 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.
Read the 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.
- Conditions
- Recurrent Depression
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT)
- Keywords
- Recurrent depression, Mental Health
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months
Secondary outcomes (5)
Health status
Quality of life
Coping
Fear
Rumination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startMar 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Flemish Community
- Investigators
- Kees van Heeringen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259506
- Sponsor's protocol ID
- 2005/195
- Status last verified
- Jun 2009
- First submitted
- 28 Nov 2005
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00259506
- Acronym / sponsor ID
- 2005/195
- Conditions
- Recurrent Depression
- Keywords
- Recurrent depression, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Ministry of the Flemish Community
- Study start
- Mar 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Behavioural | – |
Primary outcome
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months
5 secondary outcomes
Health status
Quality of life
Coping
Fear
Rumination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kees van Heeringen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) in people with Recurrent Depression, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to implement MBCT in a Flemish region. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.