Recurrent DepressionMBCL-RDNCT02059200
Mindfulness Based Compassionate Living in Recurrent Depression
A study testing Mindfulness Based Compassionate Living in people with Recurrent Depression, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new… 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 Compassionate Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to Nov 2015
- 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
- Recurrent depression according to the DSM-IV criteria.
- Having participated in an MBCT training (>= 4 sessions)
Who cannot join
- One or more previous (hypo)manic episodes according to DSM-IV criteria.
- Primary psychotic disorder, e.g. schizophrenia or delusions.
- Clinically relevant neurological conditions (e.g. brain trauma or dementia) or somatic conditions (e.g. cancer, AIDS) that could be related to the depression.
- Current alcohol and/or drug abuse.
- Use of high dosages of benzodiazepines.
- Recent electro convulsive therapy (ECT) (less than 3 months ago).
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- Problems impeding participating in a group, such as severe borderline personality disorder.
- No prior experience with MBCT.
- Problems impeding completing the questionnaires, such as cognitive dysfunctions (only assessed if suspected).
- Subnormal intelligence (IQ < 80) (only assessed if suspected).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. Ergo, there is room for improvement.
Especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. It is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of MBCT.
The research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received MBCT training?
- Conditions
- Recurrent Depression
- Being tested
- Mindfulness Based Compassionate Living
- Keywords
- Randomised controlled trial, Recurrent depression, Mindfulness training, Compassion training (MBCL), Fear of Compassion, Added value Compassion
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Compassionate LivingBehavioural
Also called MBCL, Mindfulness Based Compassion Training
The MBCL program consists of eight biweekly group sessions of 2.5 hours, in which the participants get formal meditation exercises, some theoretical information and participate in inquiry on the meditation exercises and homework assignments. Homework assignments are given after every session, consisting of formal and informal meditation exercises primarily and some diary instructions.
| Study group | Role | What they receive |
|---|---|---|
| MBCL + TAU | Experimental | This cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual. Receives: Behavioral: Mindfulness Based Compassionate Living |
| TAU | No intervention | This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II
The BDI-II measures depression symptoms. Measurements will be taken at baseline, end of treatment/control and follow up.
Measured: 1 year
Secondary outcomes (8)
Self-Compassion Scale
The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
Five Facet Mindfulness Questionnaire
The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
The Acceptance and Action Questionnaire-II
The AAQ-II measures Experiential Avoidance. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
Fears of Compassion Scale (3)
The FoCS (3) measures fear of Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
Types of Positive Affect Scale
The TPAS measures Positive Affect. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
The World Health Organization Quality of Life Scale
The WHO-QoL measures Quality of Life. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
The Ruminative Response Scale
The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.
Measured: 1 year
The Childhood Trauma Questionnaire
The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent DepressionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Triodos Foundation
- Responsible party
- Principal investigator, Anne Speckens, Radboud University Medical Center
- Investigators
- Anne Speckens, Professor, Principal investigator, University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059200
- Sponsor's protocol ID
- MFN-MBCL-2013-2017
- Acronym
- MBCL-RD
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2014
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Schuling R, Huijbers MJ, van Ravesteijn H, Donders R, Cillessen L, Kuyken W, Speckens AEM. Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up. J Affect Disord. 2020 Aug 1;273:265-273. doi: 10.1016/j.jad.2020.03.182. Epub 2020 May 4.
PubMed 32421612Schuling R, Huijbers MJ, van Ravesteijn H, Donders R, Kuyken W, Speckens AE. A parallel-group, randomized controlled trial into the effectiveness of Mindfulness-Based Compassionate Living (MBCL) compared to treatment-as-usual in recurrent depression: Trial design and protocol. Contemp Clin Trials. 2016 Sep;50:77-83. doi: 10.1016/j.cct.2016.07.014. Epub 2016 Jul 21.
PubMed 27451354
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
- ClinicalTrials.gov ID
- NCT02059200
- Acronym / sponsor ID
- MBCL-RD / MFN-MBCL-2013-2017
- Conditions
- Recurrent Depression
- Keywords
- Randomised controlled trial, Recurrent depression, Mindfulness training, Compassion training (MBCL), Fear of Compassion, Added value Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Triodos Foundation
- Study start
- Jul 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Feb 2014 (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.
Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. Ergo, there is room for improvement.
Especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. It is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of MBCT.
The research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received MBCT training?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCL + TAU | Experimental | Behavioral: Mindfulness Based Compassionate LivingThis cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual. |
| TAU | No intervention | –This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent depression according to the DSM-IV criteria.
- Having participated in an MBCT training (>= 4 sessions)
Key exclusion criteria (10 listed)
- One or more previous (hypo)manic episodes according to DSM-IV criteria.
- Primary psychotic disorder, e.g. schizophrenia or delusions.
- Clinically relevant neurological conditions (e.g. brain trauma or dementia) or somatic conditions (e.g. cancer, AIDS) that could be related to the depression.
- Current alcohol and/or drug abuse.
- Use of high dosages of benzodiazepines.
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 Compassionate LivingAlso: MBCL, Mindfulness Based Compassion TrainingThe MBCL program consists of eight biweekly group sessions of 2.5 hours, in which the participants get formal meditation exercises, some theoretical information and participate in inquiry on the meditation exercises and homework assignments. Homework assignments are given after every session, consisting of formal and informal meditation exercises primarily and some diary instructions. | Behavioural | MBCL + TAU |
Primary outcome
Beck Depression Inventory-II
Time frame: 1 year
The BDI-II measures depression symptoms. Measurements will be taken at baseline, end of treatment/control and follow up.
8 secondary outcomes
Self-Compassion Scale
Time frame: 1 year
Five Facet Mindfulness Questionnaire
Time frame: 1 year
The Acceptance and Action Questionnaire-II
Time frame: 1 year
Fears of Compassion Scale (3)
Time frame: 1 year
Types of Positive Affect Scale
Time frame: 1 year
The World Health Organization Quality of Life Scale
Time frame: 1 year
The Ruminative Response Scale
Time frame: 1 year
The Childhood Trauma Questionnaire
Time frame: Baseline
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 18 Apr 2023.
- Derived from this study: PubMed 32421612Schuling R, Huijbers MJ, van Ravesteijn H, Donders R, Cillessen L, Kuyken W, Speckens AEM. Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up. J Affect Disord. 2020 Aug 1;273:265-273. doi: 10.1016/j.jad.2020.03.182. Epub 2020 May 4.
- Derived from this study: PubMed 27451354Schuling R, Huijbers MJ, van Ravesteijn H, Donders R, Kuyken W, Speckens AE. A parallel-group, randomized controlled trial into the effectiveness of Mindfulness-Based Compassionate Living (MBCL) compared to treatment-as-usual in recurrent depression: Trial design and protocol. Contemp Clin Trials. 2016 Sep;50:77-83. doi: 10.1016/j.cct.2016.07.014. Epub 2016 Jul 21.
- Related infoLink 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.
Anne Speckens, Professor principal investigator
University Medical Center Nijmegen
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 Compassionate Living in people with Recurrent Depression, 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 10 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 18 Apr 2023. 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?
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?
Beck Depression Inventory-II (time frame: 1 year). 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 NCT02059200, which also lists 2 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 18 Apr 2023.