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CompletedNCT02059200MBCL-RDUpdated Apr 18, 2023

Mindfulness Based Compassionate Living in Recurrent Depression

An interventional study of Mindfulness Based Compassionate Living in Recurrent Depression, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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?

02

Conditions studied

  • Recurrent Depression

Keywords

  • Randomised controlled trial
  • Recurrent depression
  • Mindfulness training
  • Compassion training (MBCL)
  • Fear of Compassion
  • Added value Compassion
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 122 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    MBCL + TAU

    This cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual.

    Behavioral: Mindfulness Based Compassionate Living

  • No intervention
    TAU

    This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc.

Interventions

  • BehavioralMindfulness 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.

    Also known as: MBCL, Mindfulness Based Compassion Training

06

What researchers measure

Primary outcomes

  1. Beck Depression Inventory-II

    The BDI-II measures depression symptoms. Measurements will be taken at baseline, end of treatment/control and follow up.

    Time frame: 1 year

Secondary outcomes

  1. Self-Compassion Scale

    The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.

    Time frame: 1 year

  2. Five Facet Mindfulness Questionnaire

    The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

  5. Types of Positive Affect Scale

    The TPAS measures Positive Affect. Measurements will be taken at baseline, end of treatment/control and follow-up.

    Time frame: 1 year

  6. 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.

    Time frame: 1 year

  7. The Ruminative Response Scale

    The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.

    Time frame: 1 year

  8. The Childhood Trauma Questionnaire

    The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.

    Time frame: Baseline

07

Study locations

1 site
  • University Medical Center Nijmegen
    Nijmegen, Gelderland, Netherlands
08

References and documents

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 32421612 ↗
  • Schuling 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 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02059200
Lead sponsor
Radboud University Medical Center
Collaborators
Triodos Foundation
Responsible party
Anne Speckens (Professor, Radboud University Medical Center) — Principal investigator
First posted
Feb 11, 2014
Start date
Jul 2013
Primary completion
May 2015
Completion
Nov 2015
Last update
Apr 18, 2023

Study contacts

Anne Speckens, Professor
principal investigator · University Medical Center Nijmegen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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