Depressive Disorder, MajorNCT01038765
Mindfulness Based Cognitive Therapy for Recurrent Depression
A study testing Mindfulness Based Cognitive Therapy in people with Depressive Disorder, Major, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- 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
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 3 or more previous depressive episodes
- if treated with medication: constant dose of at least 6 weeks
Who cannot join
- Bipolar Disorder
- Psychotic disorder
- Neurological or somatic illness affecting depression or outcome measures
- Current alcohol or drugs dependency
- Acute need of psychiatric treatment
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525 GC
About this study
Official title: Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
Read the detailed description
Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.
Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.
Study aims are:
- to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
- to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
- to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment
In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.
- Conditions
- Depressive Disorder, Major
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Mindfulness Based Cognitive Therapy Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Waiting list control group | No intervention | 3-month waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score.
Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).
Measured: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Secondary outcomes (1)
Self-report Depressive Symptoms
Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63.
Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63).
Measured: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJan 2005
- Primary completionMar 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds Psychische Gezondheid
- Responsible party
- Principal investigator, Anne Speckens, Radboud University Medical Center
- Investigators
- Anne EM Speckens, Prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038765
- Sponsor's protocol ID
- MFN-2005-2010
- Other IDs
- 2005 6028
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2009
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PubMed 10965637Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
PubMed 14756612Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
PubMed 19249017Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23.
PubMed 16797486Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203. doi: 10.1348/147608306X116016.
PubMed 17535594van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3.
PubMed 22017808
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
- ClinicalTrials.gov ID
- NCT01038765
- Acronym / sponsor ID
- MFN-2005-2010
- Conditions
- Depressive Disorder, Major
- Keywords
- Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Fonds Psychische Gezondheid
- Study start
- Jan 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
Detailed description
Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.
Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.
Study aims are:
- to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
- to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
- to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment
In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.
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 | Experimental | Behavioral: Mindfulness Based Cognitive TherapyMindfulness Based Cognitive Therapy |
| Waiting list control group | No intervention | –3-month waiting list group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 3 or more previous depressive episodes
- if treated with medication: constant dose of at least 6 weeks
Key exclusion criteria (5 listed)
- Bipolar Disorder
- Psychotic disorder
- Neurological or somatic illness affecting depression or outcome measures
- Current alcohol or drugs dependency
- Acute need of psychiatric treatment
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 TherapyAlso: MBCT8-weeks group based intervention of mindfulness and cognitive behavioural techniques | Behavioural | Mindfulness Based Cognitive Therapy |
Primary outcome
Depressive Symptoms
Time frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).
1 secondary outcome
Self-report Depressive Symptoms
Time frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10965637Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
- Background: PubMed 14756612Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
- Background: PubMed 19249017Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
- Background: PubMed 16797486Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23.
- Background: PubMed 17535594Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203. doi: 10.1348/147608306X116016.
- Derived from this study: PubMed 22017808van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3.
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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.
Anne EM Speckens, Prof. dr. principal investigator
Radboud University Medical Center
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 in people with Depressive Disorder, Major, run by Radboud University Medical Center at 1 site in Netherlands.
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 30 Jan 2024. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depressive Symptoms (time frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038765, which also lists 6 linked publications.
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 30 Jan 2024.