Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder

Major Depressive Disorder, Recurrent Clinical Trial

Official title:

Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353493
• Other study ID #: 314 #2016-051-000001
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age above 18 years

2. Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression

3. Recurrent MDD evaluated a being the primary disorder.

4. Danish literacy

Exclusion Criteria:

1. A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy

2. Formal concurrent psychotherapy

3. Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction

4. Anti-psychotic medication and benzodiazepines

5. Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder, Recurrent
• Recurrence

Intervention

Behavioral:
• MBCT
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).

Other:
• TAU
Treatment as usual (TAU)

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Harvard Medical School, University of Oxford, University of York, VIA University College

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.	HG-U133 Plus 2.0 GeneChip (Affymetrix)	Baseline and 8 weeks
Primary	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
Secondary	Change in mindfulness skills	Five Factor Mindfulness Questionnaire (FFMQ)	Baseline and 8 weeks
Secondary	Change in decentering	Experiences Questionaire (EQ)	Baseline and 8 weeks
Secondary	Change in rumination	Rumination Response Scale (RRS)	Baseline and 8 weeks
Secondary	Change in emotional processing bias	Facial Expression Recognition task (FERT)	Baseline and 8 weeks
Secondary	Change in interoceptive awareness	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Baseline and 8 weeks
Secondary	Change in perceived stress	Perceived Stress Scale (PSS)	Baseline and 8 weeks
Secondary	Time to relapse or recurrence of depression	Structured clinical interview for DSM-IV	12 months follow up
Secondary	Change in depressive symptoms	Quick Inventory for Depressive Symptomology (QIDS-SR)	Baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	Change in gene expression of norepinephrine transporter	Norepinephrine transporter (NET)	Baseline and 8 weeks
Secondary	Change in gene expression of glutamate receptor	Glutamate receptor (GRM7)	Baseline and 8 weeks
Secondary	Change in gene expression of TNF	Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)	Baseline and 8 weeks
Secondary	Change in protein expression of tumor necrosis factor	Tumor necrosis factor	Baseline and 8 weeks
Secondary	cRP expression	c reactive protein expression	Baseline and 8 weeks
Secondary	Change in NF-kB gene expression	Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression	Baseline and 8 weeks
Secondary	Change in NF-kB protein expression	Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression	Baseline and 8 weeks
Secondary	Change in INFG gene expression	Interferon gamma gene expresison	Baseline and 8 weeks
Secondary	Change in Interferon gamma protein expression	Interferon gamma protein expresison	Baseline and 8 weeks
Secondary	Mitochondrial DNA Copy Number	Copy number is assessed using quantitative real-time-PCR	Baseline and 8 weeks

External Links

•   Study website