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

NCT ID: NCT02226042

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Major Depression (in Remission)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mindfulness-based Cognitive Therapy

Intervention Type: BEHAVIORAL

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.

Non-MBCT arm

Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy volunteers

Individuals who have never experienced major depression

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBCT

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Kate Williams

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Manchester

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34272797 (View on PubMed)

Other Identifiers

MBCTMechanisms

Identifier Type: -

Identifier Source: org_study_id