Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)

Not Applicable

Completed

• Conditions: Major Depression (in Remission)

• Registration Number: NCT02226042
• Lead Sponsor: University of Manchester

Brief Summary

This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme.

Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk.

The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.

Detailed Description

There will be three groups in total.

* The first group will take 36 participants in remission from major depression (rMDD) through the 8 week MBCT program.

* A control group of 36 rMDD participants will not receive the intervention.

* A group of never depressed healthy control participants will also be recruited.

Research visits for participants not undergoing MBCT will be separated by an 8 week gap.

All participants will be seen before and after the 8 weeks for completion of neuropsychological assessments and questionnaires.

rMDD participants will be followed up over the following 12 months to identify any predictors of relapse.

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-26
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2017-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Participants with remitted depression (rMDD):

• At least two previous episodes of DSM-IV major depression in adulthood, diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I).
• Full or partial remission for at least three months with two depressive episodes within the last five years.
• A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale (MADRS) mood assessment.
• If on medication, no recent or planned major changes

Healthy volunteers:

• In good psychological health screened with the M.I.N.I

All participants:

• in good physical health (to reduce risk of confounding physical health problems).
• sufficiently fluent in English to ensure valid understanding and completion of the tasks.
• minimum I.Q level of 80 to ensure sufficient understanding of the neurocognitive tasks administered.
• colour vision and acuity within normal/corrected to normal limits.

Exclusion criteria:

• Any current mental health diagnosis (DSM-IV diagnosis including current major depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD), substance abuse or dependence, eating disorders)
• Physical health or neurological disorders that might interfere with the interpretation of the tasks, including a history of significant head injury.
• In addition healthy volunteers will be without a history mental health disorders (DSM-IV)
• Current or previous experience of mindfulness-based treatments or extensive cognitive behavioural treatment, or planned participation in psychological treatments during the key time for the study (between pre and post visits).
• Planned major alteration in drug treatment for depression between pre and post visits.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures	measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)	Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).

Secondary Outcome Measures

Name	Time	Method
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures	measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)	One neuropsychological measure of rumination has been developed and will be administered at baseline and immediately after MBCT/8 week gap (8 weeks post baseline).; Self-report questionnaires will be administered at baseline and after MBCT/8 week gap (8 weeks post baseline) and at subsequent follow-up visits (3,6,12 months).
Changes in attention regulation following MBCT	measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
Changes in brain structure following MBCT	measured at baseline and after the intervention (8 weeks post baseline)

Trial Locations

Locations (1)

University of Manchester; 🇬🇧 Manchester, Greater Manchester, United Kingdom