Major Depressive DisorderMBCTNCT00943033
Study of Mindfulness-Based Cognitive Therapy
A study testing Mindfulness-Based Cognitive Therapy in people with Major Depressive Disorder, run by Binghamton University.
Trial summary
Research aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jul 2010
- 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
- History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year
- Can speak, read, and understand English
Who cannot join
- Meet Criteria for Current Major Depressive Episode or are in partial remission
- BDI-II score above 19
- Abuse alcohol or drugs
- Current Dysthymic Disorder
- History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa
About this study
Official title: Toward Identifying the Mechanisms of Action in Mindfulness-Based Cognitive Therapy
Research aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy
- Conditions
- Major Depressive Disorder
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- MBCT, Mindfulness-Based Cognitive Therapy, Mindfulness, Meditation, Relapse Prevention, Recurrent Depression, Depression, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
Mindfulness-Based Cognitive Therapy for the prevention of depressive relapse/recurrence
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy plus treatment as usual | Experimental | Not described Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
| MBCT Waitlist plus Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Attention to Response Task
Measured: zero to four weeks pre-treatment and zero to three weeks post-treatment
Secondary outcomes (1)
Five Facet Mindfulness Questionnaire
Measured: zero to four weeks pre-treatment and zero to three weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Barnes, Binghamton University
- Investigators
- Sean M. Barnes, MS, Principal investigator, Binghamton University SUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943033
- Sponsor's protocol ID
- MLI-FJVRF-08-SMB
- Acronym
- MBCT
- Status last verified
- Sep 2012
- First submitted
- 13 Jul 2009
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Identifying the Mechanisms of Action in Mindfulness-Based Cognitive Therapy
- ClinicalTrials.gov ID
- NCT00943033
- Acronym / sponsor ID
- MBCT / MLI-FJVRF-08-SMB
- Conditions
- Major Depressive Disorder
- Keywords
- MBCT, Mindfulness-Based Cognitive Therapy, Mindfulness, Meditation, Relapse Prevention, Recurrent Depression, Depression, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Jul 2009 (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 aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy plus treatment as usual | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy |
| MBCT Waitlist plus Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year
- Can speak, read, and understand English
Key exclusion criteria (5 listed)
- Meet Criteria for Current Major Depressive Episode or are in partial remission
- BDI-II score above 19
- Abuse alcohol or drugs
- Current Dysthymic Disorder
- History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa
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 TherapyMindfulness-Based Cognitive Therapy for the prevention of depressive relapse/recurrence | Behavioural | Mindfulness-Based Cognitive Therapy plus treatment as usual |
Primary outcome
Sustained Attention to Response Task
Time frame: zero to four weeks pre-treatment and zero to three weeks post-treatment
1 secondary outcome
Five Facet Mindfulness Questionnaire
Time frame: zero to four weeks pre-treatment and zero to three weeks post-treatment
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 21 Sep 2012.
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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.
Sean M. Barnes, MS principal investigator
Binghamton University SUNY
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Major Depressive Disorder, run by Binghamton University.
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 2 inclusion and 5 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 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Sustained Attention to Response Task (time frame: zero to four weeks pre-treatment and zero to three weeks post-treatment). 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 21 Sep 2012.