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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
80
Aarhus University
Aarhus, Denmark
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
Time frame: Baseline and 8 weeks
Change in mindfulness skills
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Baseline and 8 weeks
Change in decentering
Experiences Questionaire (EQ)
Time frame: Baseline and 8 weeks
Change in rumination
Rumination Response Scale (RRS)
Time frame: Baseline and 8 weeks
Change in emotional processing bias
Facial Expression Recognition task (FERT)
Time frame: Baseline and 8 weeks
Change in interoceptive awareness
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Baseline and 8 weeks
Change in perceived stress
Perceived Stress Scale (PSS)
Time frame: Baseline and 8 weeks
Time to relapse or recurrence of depression
Structured clinical interview for DSM-IV
Time frame: 12 months follow up
Change in depressive symptoms
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Quick Inventory for Depressive Symptomology (QIDS-SR)
Time frame: 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,
Time frame: 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,
Time frame: Baseline and 8 weeks
Change in gene expression of norepinephrine transporter
Norepinephrine transporter (NET)
Time frame: Baseline and 8 weeks
Change in gene expression of glutamate receptor
Glutamate receptor (GRM7)
Time frame: Baseline and 8 weeks
Change in gene expression of TNF
Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
Time frame: Baseline and 8 weeks
Change in protein expression of tumor necrosis factor
Tumor necrosis factor
Time frame: Baseline and 8 weeks
cRP expression
c reactive protein expression
Time frame: Baseline and 8 weeks
Change in NF-kB gene expression
Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
Time frame: Baseline and 8 weeks
Change in NF-kB protein expression
Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
Time frame: Baseline and 8 weeks
Change in INFG gene expression
Interferon gamma gene expresison
Time frame: Baseline and 8 weeks
Change in Interferon gamma protein expression
Interferon gamma protein expresison
Time frame: Baseline and 8 weeks
Mitochondrial DNA Copy Number
Copy number is assessed using quantitative real-time-PCR
Time frame: Baseline and 8 weeks