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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| VIA University College | OTHER |
| University of York | OTHER |
| Harvard Medical School (HMS and HSDM) |
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The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.
AIM AND HYPOTHESES
The primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.
Controlled design:
First, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).
Prospective design:
We aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT + TAU | Experimental | Mindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy. |
|
| TAU | Other | Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT | Behavioral | Mindfulness-Based Cognitive Therapy (MBCT) is an 8 week manualised group intervention. MBCT will be delivered according to the manual by Segal, Williams & Teasdale (2013). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neural connectivity | Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mindfulness skills | Five Factor Mindfulness Questionnaire (FFMQ) | Baseline and 8 weeks |
| Change in decentering | Experiences Questionaire (EQ) |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI BOLD secondary and whole brain analyses | fMRI BOLD whole brain analyses (data-driven) and secondary subcortical seed-based analyses: As seeds we preselect hippocampus, the amygdala and striatum | Baseline and 8 weeks |
| Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Maj van der Velden, Msc | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36328822 | Derived | van der Velden AM, Scholl J, Elmholdt EM, Fjorback LO, Harmer CJ, Lazar SW, O'Toole MS, Smallwood J, Roepstorff A, Kuyken W. Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial. Biol Psychiatry. 2023 Feb 1;93(3):233-242. doi: 10.1016/j.biopsych.2022.06.038. Epub 2022 Jul 22. |
| Label | URL |
|---|---|
| Study website | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| OTHER |
Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
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Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
| TAU | Other | Treatment as usual (TAU) |
|
| Baseline and 8 weeks |
| Change in rumination | Rumination Response Scale (RRS) | Baseline and 8 weeks |
| Change in emotional processing bias | Facial Expression Recognition task (FERT) | Baseline and 8 weeks |
| Change in interoceptive awareness | Multidimensional Assessment of Interoceptive Awareness (MAIA) | Baseline and 8 weeks |
| Change in perceived stress | Perceived Stress Scale (PSS) | Baseline and 8 weeks |
| Time to relapse or recurrence of depression | Structured clinical interview for DSM-IV | 12 months follow up |
| Change in depressive symptoms | Quick Inventory for Depressive Symptomology (QIDS-SR) | Baseline and 8 weeks |
| Change in interleukin gene expression | IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13, | Baseline and 8 weeks |
| Change in interleukin protein expression | IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13, | Baseline and 8 weeks |
| Change in gene expression of norepinephrine transporter | Norepinephrine transporter (NET) | Baseline and 8 weeks |
| Change in gene expression of glutamate receptor | Glutamate receptor (GRM7) | Baseline and 8 weeks |
| Change in gene expression of TNF | Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa) | Baseline and 8 weeks |
| Change in protein expression of tumor necrosis factor | Tumor necrosis factor | Baseline and 8 weeks |
| cRP expression | c reactive protein expression | Baseline and 8 weeks |
| Change in NF-kB gene expression | Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression | Baseline and 8 weeks |
| Change in NF-kB protein expression | Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression | Baseline and 8 weeks |
| Change in INFG gene expression | Interferon gamma gene expresison | Baseline and 8 weeks |
| Change in Interferon gamma protein expression | Interferon gamma protein expresison | Baseline and 8 weeks |
| Mitochondrial DNA Copy Number | Copy number is assessed using quantitative real-time-PCR | Baseline and 8 weeks |
HG-U133 Plus 2.0 GeneChip (Affymetrix) |
| Baseline and 8 weeks |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |