Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
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|ClinicalTrials.gov Identifier: NCT02226042|
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : May 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression (in Remission)||Behavioral: Mindfulness-based Cognitive Therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2017|
Experimental: Mindfulness-based Cognitive Therapy
Individuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme
Behavioral: Mindfulness-based Cognitive Therapy
MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.
Other Name: MBCT
No Intervention: Non-MBCT arm
Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme
No Intervention: Healthy volunteers
Individuals who have never experienced major depression
- Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures [ Time Frame: 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).
- Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures [ Time Frame: 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 [ Time Frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) ]
- Changes in brain structure following MBCT [ Time Frame: measured at baseline and after the intervention (8 weeks post baseline) ]
- Changes in emotional processing [ Time Frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) ]Other neuropsychological assessments of emotional processing (face emotion recognition, memory, cognitive flexibility) will be assessed at baseline and after MBCT/8 week gap (8 weeks post baseline).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226042
|University of Manchester|
|Manchester, Greater Manchester, United Kingdom, M13 9PT|