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Clinical Trials/NCT02226042
NCT02226042
Completed
Not Applicable

Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy

University of Manchester1 site in 1 country112 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression (in Remission)
Sponsor
University of Manchester
Enrollment
112
Locations
1
Primary Endpoint
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Williams

PhD Student

University of Manchester

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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))
  • 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))

Study Sites (1)

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