Major Depression (in Remission) Clinical Trial
Official title:
Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy
| Verified date | May 2018 |
| Source | University of Manchester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | October 2017 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Manchester | Manchester | Greater Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manchester |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Changes in emotional processing | 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). | measured at baseline and after the intervention/8 week gap (8 weeks post baseline) | |
| Primary | 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 | 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). |
measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total) | |
| Secondary | Changes in attention regulation following MBCT | measured at baseline and after the intervention/8 week gap (8 weeks post baseline) | ||
| Secondary | Changes in brain structure following MBCT | measured at baseline and after the intervention (8 weeks post baseline) |