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Mindfulness Based Compassionate Living in Recurrent Depression (MBCL-RD)

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ClinicalTrials.gov Identifier: NCT02059200
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Triodos Foundation, the Netherlands
Information provided by (Responsible Party):
Anne Speckens, Radboud University Medical Center

Study Description
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Brief 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 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?


Condition or disease Intervention/treatment Phase
Recurrent Depression Behavioral: Mindfulness Based Compassionate Living Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
Study Start Date : July 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MBCL + TAU
This cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual.
 Behavioral: Mindfulness Based Compassionate Living
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.
Other Names:
  • MBCL
  • Mindfulness Based Compassion Training
No Intervention: TAU
This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Self-Compassion Scale [ Time Frame: 1 year ]
    The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.

  2. Five Facet Mindfulness Questionnaire [ Time Frame: 1 year ]
    The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.

  3. The Acceptance and Action Questionnaire-II [ Time Frame: 1 year ]
    The AAQ-II measures Experiential Avoidance. Measurements will be taken at baseline, end of treatment/control and follow-up.

  4. Fears of Compassion Scale (3) [ Time Frame: 1 year ]
    The FoCS (3) measures fear of Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.

  5. Types of Positive Affect Scale [ Time Frame: 1 year ]
    The TPAS measures Positive Affect. Measurements will be taken at baseline, end of treatment/control and follow-up.

  6. The World Health Organization Quality of Life Scale [ Time Frame: 1 year ]
    The WHO-QoL measures Quality of Life. Measurements will be taken at baseline, end of treatment/control and follow-up.

  7. The Ruminative Response Scale [ Time Frame: 1 year ]
    The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.

  8. The Childhood Trauma Questionnaire [ Time Frame: Baseline ]
    The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recurrent depression according to the DSM-IV criteria.
  2. Having participated in an MBCT training (>= 4 sessions)

Exclusion Criteria:

  1. One or more previous (hypo)manic episodes according to DSM-IV criteria.
  2. Primary psychotic disorder, e.g. schizophrenia or delusions.
  3. Clinically relevant neurological conditions (e.g. brain trauma or dementia) or somatic conditions (e.g. cancer, AIDS) that could be related to the depression.
  4. Current alcohol and/or drug abuse.
  5. Use of high dosages of benzodiazepines.
  6. Recent electro convulsive therapy (ECT) (less than 3 months ago).
  7. Problems impeding participating in a group, such as severe borderline personality disorder.
  8. No prior experience with MBCT.
  9. Problems impeding completing the questionnaires, such as cognitive dysfunctions (only assessed if suspected).
  10. Subnormal intelligence (IQ < 80) (only assessed if suspected).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059200


Locations
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Netherlands
University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
Triodos Foundation, the Netherlands
Investigators
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Principal Investigator: Anne Speckens, Professor University Medical Center Nijmegen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anne Speckens, Professor, Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02059200    
Other Study ID Numbers: MFN-MBCL-2013-2017
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Anne Speckens, Radboud University Medical Center:
Randomised controlled trial
Recurrent depression
Mindfulness training
 Compassion training (MBCL)
Fear of Compassion
Added value Compassion
Additional relevant MeSH terms:
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Recurrence
Depression
Depressive Disorder
Disease Attributes
 Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders