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

April 14, 2023 updated by: Anne Speckens, Radboud University Medical Center

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • University Medical Center Nijmegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
The Childhood Trauma Questionnaire
Time Frame: Baseline
The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Triodos Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFN-MBCL-2013-2017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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