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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
Sponsor:
Information provided by (Responsible Party):
Kate Williams, 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.


Condition or disease Intervention/treatment Phase
Major Depression (in Remission) Behavioral: Mindfulness-based Cognitive Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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 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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).


  2. Changes in attention regulation following MBCT [ Time Frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) ]
  3. Changes in brain structure following MBCT [ Time Frame: measured at baseline and after the intervention (8 weeks post baseline) ]

Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
University of Manchester
Manchester, Greater Manchester, United Kingdom, M13 9PT
Sponsors and Collaborators
University of Manchester

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Responsible Party: Kate Williams, PhD Student, University of Manchester
ClinicalTrials.gov Identifier: NCT02226042    
Other Study ID Numbers: MBCTMechanisms
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders