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

Not Applicable

Completed

• Conditions: Major Depressive Disorder, Recurrent
• Interventions: Behavioral: MBCT; Other: TAU

• Registration Number: NCT03353493
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-27
• Primary Completion: 2018-06-01
• Status Verified: 2019-06
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBCT + TAU	MBCT	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.
MBCT + TAU	TAU	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	TAU	Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.

Primary Outcome Measures

Name	Time	Method
Change in neural connectivity	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

Secondary Outcome Measures

Name	Time	Method
Time to relapse or recurrence of depression	12 months follow up	Structured clinical interview for DSM-IV
Mitochondrial DNA Copy Number	Baseline and 8 weeks	Copy number is assessed using quantitative real-time-PCR
Change in perceived stress	Baseline and 8 weeks	Perceived Stress Scale (PSS)
Change in interleukin gene expression	Baseline and 8 weeks	IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Change in decentering	Baseline and 8 weeks	Experiences Questionaire (EQ)
Change in emotional processing bias	Baseline and 8 weeks	Facial Expression Recognition task (FERT)
cRP expression	Baseline and 8 weeks	c reactive protein expression
Change in INFG gene expression	Baseline and 8 weeks	Interferon gamma gene expresison
Change in depressive symptoms	Baseline and 8 weeks	Quick Inventory for Depressive Symptomology (QIDS-SR)
Change in gene expression of glutamate receptor	Baseline and 8 weeks	Glutamate receptor (GRM7)
Change in mindfulness skills	Baseline and 8 weeks	Five Factor Mindfulness Questionnaire (FFMQ)
Change in rumination	Baseline and 8 weeks	Rumination Response Scale (RRS)
Change in protein expression of tumor necrosis factor	Baseline and 8 weeks	Tumor necrosis factor
Change in NF-kB gene expression	Baseline and 8 weeks	Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
Change in interoceptive awareness	Baseline and 8 weeks	Multidimensional Assessment of Interoceptive Awareness (MAIA)
Change in interleukin protein expression	Baseline and 8 weeks	IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Change in gene expression of norepinephrine transporter	Baseline and 8 weeks	Norepinephrine transporter (NET)
Change in gene expression of TNF	Baseline and 8 weeks	Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
Change in NF-kB protein expression	Baseline and 8 weeks	Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
Change in Interferon gamma protein expression	Baseline and 8 weeks	Interferon gamma protein expresison

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus, Denmark