Clinical trial NCT02226042: Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
Official title: Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression (in Remission)
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
timeFrame: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)
Secondary outcomes:
measure: Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
timeFrame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)
measure: Changes in attention regulation following MBCT
timeFrame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
measure: Changes in brain structure following MBCT
timeFrame: measured at baseline and after the intervention (8 weeks post baseline)
Other outcomes:
measure: Changes in emotional processing
timeFrame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
References:
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.