Back to resultsInvestigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
Primary Purpose
Major Depression (in Remission)
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness-based Cognitive Therapy
Sponsored by
About this trial
This is an interventional other trial for Major Depression (in Remission)
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.
Sites / Locations
- University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Mindfulness-based Cognitive Therapy
Non-MBCT arm
Healthy volunteers
Arm 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
Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme
Individuals who have never experienced major depression
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
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).
Changes in attention regulation following MBCT
Changes in brain structure following MBCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02226042
Brief Title
Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
Official Title
Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression (in Remission)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based Cognitive Therapy
Arm Type
Experimental
Arm 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
Arm Title
Non-MBCT arm
Arm Type
No Intervention
Arm Description
Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme
Arm Title
Healthy volunteers
Arm Type
No Intervention
Arm Description
Individuals who have never experienced major depression
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Cognitive Therapy
Other Intervention Name(s)
MBCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
Description
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).
Time Frame
measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)
Secondary Outcome Measure Information:
Title
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
Description
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).
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)
Title
Changes in attention regulation following MBCT
Time Frame
measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
Title
Changes in brain structure following MBCT
Time Frame
measured at baseline and after the intervention (8 weeks post baseline)
Other Pre-specified Outcome Measures:
Title
Changes in emotional processing
Description
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).
Time Frame
measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34272797
Citation
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.
Results Reference
derived
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Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
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