An interventional study of MBCT and TAU in Major Depressive Disorder, Recurrent, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 80 is close to the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: MBCT · Other: TAU
Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
Other: TAU
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)
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
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
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
Time frame: Baseline and 8 weeks
Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.
HG-U133 Plus 2.0 GeneChip (Affymetrix)
Time frame: Baseline and 8 weeks
Plan to share: No
Ran from Feb 2017 to primary completion in Jun 2018, 15 months.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's 15 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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