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

Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy

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.

Study Overview

• Status: Completed
• Conditions: Major Depression (in Remission)
• Intervention / Treatment: Behavioral: Mindfulness-based Cognitive Therapy

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9PT
      • University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures	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).	measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures	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).	measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in emotional processing	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).	measured at baseline and after the intervention/8 week gap (8 weeks post baseline)

Collaborators and Investigators

• Sponsor: University of Manchester

Publications and helpful links

General Publications

• Williams K, Hartley S, Anderson IM, Birtwell K, Dowson M, Elliott R, Taylor P. An ongoing process of reconnection: A qualitative exploration of mindfulness-based cognitive therapy for adults in remission from depression. Psychol Psychother. 2022 Mar;95(1):173-190. doi: 10.1111/papt.12357. Epub 2021 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MBCTMechanisms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO