NCT02059200

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

January 30, 2014

Last Update Submit

April 14, 2023

Conditions

Keywords

Randomised controlled trialRecurrent depressionMindfulness trainingCompassion training (MBCL)Fear of CompassionAdded value Compassion

Outcome Measures

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.

    1 year

Secondary Outcomes (8)

  • Self-Compassion Scale

    1 year

  • Five Facet Mindfulness Questionnaire

    1 year

  • The Acceptance and Action Questionnaire-II

    1 year

  • Fears of Compassion Scale (3)

    1 year

  • Types of Positive Affect Scale

    1 year

  • +3 more secondary outcomes

Study Arms (2)

MBCL + TAU

EXPERIMENTAL

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

Behavioral: Mindfulness Based Compassionate Living

TAU

NO INTERVENTION

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

Interventions

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
MBCL + TAU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Nijmegen

Nijmegen, Gelderland, Netherlands

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Anne Speckens, Professor

    University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 11, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations