Aarhus University
Aarhus, 8000, Denmark
NCT Number: NCT03353493
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aarhus, 8000, Denmark
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Treatment as usual (TAU)
Time frame: Baseline and 8 weeks
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
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Baseline and 8 weeks
Experiences Questionaire (EQ)
Time frame: Baseline and 8 weeks
Rumination Response Scale (RRS)
Time frame: Baseline and 8 weeks
Facial Expression Recognition task (FERT)
Time frame: Baseline and 8 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Baseline and 8 weeks
Perceived Stress Scale (PSS)
Time frame: 12 months follow up
Structured clinical interview for DSM-IV
Time frame: Baseline and 8 weeks
Quick Inventory for Depressive Symptomology (QIDS-SR)
Time frame: Baseline and 8 weeks
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Time frame: Baseline and 8 weeks
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Time frame: Baseline and 8 weeks
Norepinephrine transporter (NET)
Time frame: Baseline and 8 weeks
Glutamate receptor (GRM7)
Time frame: Baseline and 8 weeks
Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
Time frame: Baseline and 8 weeks
Tumor necrosis factor
Time frame: Baseline and 8 weeks
c reactive protein expression
Time frame: Baseline and 8 weeks
Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
Time frame: Baseline and 8 weeks
Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
Time frame: Baseline and 8 weeks
Interferon gamma gene expresison
Time frame: Baseline and 8 weeks
Interferon gamma protein expresison
Time frame: Baseline and 8 weeks
Copy number is assessed using quantitative real-time-PCR
Time frame: Baseline and 8 weeks
fMRI BOLD whole brain analyses (data-driven) and secondary subcortical seed-based analyses: As seeds we preselect hippocampus, the amygdala and striatum
Time frame: Baseline and 8 weeks
HG-U133 Plus 2.0 GeneChip (Affymetrix)
University of Aarhus
Other
Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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