Clinical trial NCT02059200: Mindfulness Based Compassionate Living in Recurrent Depression
Official title: The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Depression
Keywords: Randomised controlled trial
Recurrent depression
Mindfulness training
Compassion training (MBCL)
Fear of Compassion
Added value Compassion
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Triodos Foundation
First posted: 2014-02-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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).

Primary outcomes:
measure: Beck Depression Inventory-II
timeFrame: 1 year
Secondary outcomes:
measure: Self-Compassion Scale
timeFrame: 1 year
measure: Five Facet Mindfulness Questionnaire
timeFrame: 1 year
measure: The Acceptance and Action Questionnaire-II
timeFrame: 1 year
measure: Fears of Compassion Scale (3)
timeFrame: 1 year
measure: Types of Positive Affect Scale
timeFrame: 1 year
measure: The World Health Organization Quality of Life Scale
timeFrame: 1 year
measure: The Ruminative Response Scale
timeFrame: 1 year
measure: The Childhood Trauma Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
state: Gelderland
Study officials:
affiliation: University Medical Center Nijmegen
name: Anne Speckens, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.