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

NCT02226042 | Completed

• 1 other identifier: MBCTMechanisms
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression (in Remission)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Other Outcomes (1)

• Changes in emotional processing

  measured at baseline and after the intervention/8 week gap (8 weeks post baseline)

Study Arms (3)

Mindfulness-based Cognitive Therapy

EXPERIMENTAL

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

Non-MBCT arm

NO INTERVENTION

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

Healthy volunteers

NO INTERVENTION

Individuals who have never experienced major depression

Interventions

Mindfulness-based Cognitive Therapy 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.

Also known as: MBCT

Mindfulness-based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34272797 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 26, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)