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

Primary Purpose

Recurrent Depression

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness Based Compassionate Living
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Depression focused on measuring Randomised controlled trial, Recurrent depression, Mindfulness training, Compassion training (MBCL), Fear of Compassion, Added value Compassion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Medical Center Nijmegen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBCL + TAU

TAU

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-Compassion Scale
The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.
Five Facet Mindfulness Questionnaire
The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.
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.
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.
Types of Positive Affect Scale
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
The WHO-QoL measures Quality of Life. Measurements will be taken at baseline, end of treatment/control and follow-up.
The Ruminative Response Scale
The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.
The Childhood Trauma Questionnaire
The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.

Full Information

First Posted
January 30, 2014
Last Updated
April 14, 2023
Sponsor
Radboud University Medical Center
Collaborators
Triodos Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02059200
Brief Title
Mindfulness Based Compassionate Living in Recurrent Depression
Acronym
MBCL-RD
Official Title
The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
Triodos Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Depression
Keywords
Randomised controlled trial, Recurrent depression, Mindfulness training, Compassion training (MBCL), Fear of Compassion, Added value Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCL + TAU
Arm Type
Experimental
Arm Description
This cohort receives the Mindfulness Based Compassionate Living program in addition to treatment as usual.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
This cohort receives treatment as usual of any nature, e.g. psychotherapy, antidepressant medication etc.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Compassionate Living
Other Intervention Name(s)
MBCL, Mindfulness Based Compassion Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
The BDI-II measures depression symptoms. Measurements will be taken at baseline, end of treatment/control and follow up.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Self-Compassion Scale
Description
The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
Five Facet Mindfulness Questionnaire
Description
The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
The Acceptance and Action Questionnaire-II
Description
The AAQ-II measures Experiential Avoidance. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
Fears of Compassion Scale (3)
Description
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
Title
Types of Positive Affect Scale
Description
The TPAS measures Positive Affect. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
The World Health Organization Quality of Life Scale
Description
The WHO-QoL measures Quality of Life. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
The Ruminative Response Scale
Description
The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.
Time Frame
1 year
Title
The Childhood Trauma Questionnaire
Description
The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent depression according to the DSM-IV criteria. Having participated in an MBCT training (>= 4 sessions) Exclusion Criteria: 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). 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Speckens, Professor
Organizational Affiliation
University Medical Center Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Nijmegen
City
Nijmegen
State/Province
Gelderland
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32421612
Citation
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.
Results Reference
derived
PubMed Identifier
27451354
Citation
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.
Results Reference
derived
Links:
URL
http://www.radboudcentrumvoormindfulness.nl
Description
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Mindfulness Based Compassionate Living in Recurrent Depression

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