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Completed

NCT Number: NCT03353493

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years
  • Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression
  • Recurrent MDD evaluated a being the primary disorder.
  • Danish literacy

Exclusion criteria

  • 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
  • Formal concurrent psychotherapy
  • Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction
  • Anti-psychotic medication and benzodiazepines
  • 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.

Treatment and study plan

MBCT

Behavioral

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).

TAU

Other

Treatment as usual (TAU)

Primary outcomes

  1. Change in neural connectivity

    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

Secondary outcomes

  1. Change in mindfulness skills

    Time frame: Baseline and 8 weeks

    Five Factor Mindfulness Questionnaire (FFMQ)

  2. Change in decentering

    Time frame: Baseline and 8 weeks

    Experiences Questionaire (EQ)

  3. Change in rumination

    Time frame: Baseline and 8 weeks

    Rumination Response Scale (RRS)

  4. Change in emotional processing bias

    Time frame: Baseline and 8 weeks

    Facial Expression Recognition task (FERT)

  5. Change in interoceptive awareness

    Time frame: Baseline and 8 weeks

    Multidimensional Assessment of Interoceptive Awareness (MAIA)

  6. Change in perceived stress

    Time frame: Baseline and 8 weeks

    Perceived Stress Scale (PSS)

  7. Time to relapse or recurrence of depression

    Time frame: 12 months follow up

    Structured clinical interview for DSM-IV

  8. Change in depressive symptoms

    Time frame: Baseline and 8 weeks

    Quick Inventory for Depressive Symptomology (QIDS-SR)

  9. Change in interleukin gene expression

    Time frame: Baseline and 8 weeks

    IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,

  10. Change in interleukin protein expression

    Time frame: Baseline and 8 weeks

    IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,

  11. Change in gene expression of norepinephrine transporter

    Time frame: Baseline and 8 weeks

    Norepinephrine transporter (NET)

  12. Change in gene expression of glutamate receptor

    Time frame: Baseline and 8 weeks

    Glutamate receptor (GRM7)

  13. Change in gene expression of TNF

    Time frame: Baseline and 8 weeks

    Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)

  14. Change in protein expression of tumor necrosis factor

    Time frame: Baseline and 8 weeks

    Tumor necrosis factor

  15. cRP expression

    Time frame: Baseline and 8 weeks

    c reactive protein expression

  16. Change in NF-kB gene expression

    Time frame: Baseline and 8 weeks

    Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression

  17. Change in NF-kB protein expression

    Time frame: Baseline and 8 weeks

    Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression

  18. Change in INFG gene expression

    Time frame: Baseline and 8 weeks

    Interferon gamma gene expresison

  19. Change in Interferon gamma protein expression

    Time frame: Baseline and 8 weeks

    Interferon gamma protein expresison

  20. Mitochondrial DNA Copy Number

    Time frame: Baseline and 8 weeks

    Copy number is assessed using quantitative real-time-PCR

Other outcomes

  1. fMRI BOLD secondary and whole brain analyses

    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

  2. Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.

    Time frame: Baseline and 8 weeks

    HG-U133 Plus 2.0 GeneChip (Affymetrix)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • University of Oxford
  • University of York
  • VIA University College

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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