Mindfulness Based Compassionate Living in Recurrent Depression

Recurrent Depression Clinical Trial

— MBCL-RD  

Official title:

The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059200
• Other study ID #: MFN-MBCL-2013-2017
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Recurrence
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Nijmegen	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Triodos Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-Compassion Scale	The Self-Compassion Scale measures Self-Compassion. Measurements will be taken at baseline, end of treatment/control and follow-up.	1 year
Secondary	Five Facet Mindfulness Questionnaire	The FFMQ measures mindfulness skills. Measurements will be taken at baseline, end of treatment/control and follow-up.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Types of Positive Affect Scale	The TPAS measures Positive Affect. Measurements will be taken at baseline, end of treatment/control and follow-up.	1 year
Secondary	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.	1 year
Secondary	The Ruminative Response Scale	The RRS measures Rumination. Measurements will be taken at baseline, end of treatment/control and follow-up.	1 year
Secondary	The Childhood Trauma Questionnaire	The CTQ measures Childhood Adversity. Measurements will be taken at baseline only.	Baseline

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