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

U

University of Manchester

Status

Completed

Conditions

Major Depression (in Remission)

Treatments

Behavioral: Mindfulness-based Cognitive Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02226042
MBCTMechanisms

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 3 patient groups

Mindfulness-based Cognitive Therapy
Experimental group
Description:
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
Treatment:
Behavioral: Mindfulness-based Cognitive Therapy
Non-MBCT arm
No Intervention group
Description:
Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme
Healthy volunteers
No Intervention group
Description:
Individuals who have never experienced major depression

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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