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

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

Tracking Information

• First Submitted Date: January 30, 2014
• First Posted Date: February 11, 2014
• Last Update Posted Date: July 12, 2016
• Study Start Date: July 2013
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 10, 2014)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mindfulness Based Compassionate Living in Recurrent Depression
• Official Title: The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression

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?

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Recurrent Depression

Intervention

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

Study Arms

• Experimental: MBCL + TAU
  This cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual.
  Intervention: Behavioral: Mindfulness Based Compassionate Living
• No Intervention: TAU
  This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc.

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2014): 122
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02059200
• Other Study ID Numbers: MFN-MBCL-2013-2017
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anne Speckens, Radboud University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Radboud University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Triodos Foundation, the Netherlands

Investigators

• Principal Investigator: Anne Speckens, Professor; University Medical Center Nijmegen

• PRS Account: Radboud University Medical Center
• Verification Date: July 2016