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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353493
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
University of Oxford
VIA University College
University of York
Harvard Medical School (HMS and HSDM)
Information provided by (Responsible Party):
Anne Maj van der Velden, University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 8, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
Change in default mode neural connectivity [ Time Frame: Baseline and 8 weeks ]
Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory region for seed-based analyses: Default mode Network.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • Change in mindfulness skills [ Time Frame: Baseline and 8 weeks ]
    Five Factor Mindfulness Questionnaire (FFMQ)
  • Change in decentering [ Time Frame: Baseline and 8 weeks ]
    Experiences Questionaire (EQ)
  • Change in rumination [ Time Frame: Baseline and 8 weeks ]
    Rumination Response Scale (RRS)
  • Change in emotional processing bias [ Time Frame: Baseline and 8 weeks ]
    Facial Expression Recognition task (FERT)
  • Change in interoceptive awareness [ Time Frame: Baseline and 8 weeks ]
    Multidimensional Assessment of Interoceptive Awareness (MAIA)
  • Change in perceived stress [ Time Frame: Baseline and 8 weeks ]
    Perceived Stress Scale (PSS)
  • Time to relapse or recurrence of depression [ Time Frame: 12 months follow up ]
    Structured clinical interview for DSM-IV
  • Change in depressive symptoms [ Time Frame: Baseline and 8 weeks ]
    Quick Inventory for Depressive Symptomology (QIDS-SR)
  • 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,
  • 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,
  • Change in gene expression of norepinephrine transporter [ Time Frame: Baseline and 8 weeks ]
    Norepinephrine transporter (NET)
  • Change in gene expression of glutamate receptor [ Time Frame: Baseline and 8 weeks ]
    Glutamate receptor (GRM7)
  • Change in gene expression of TNF [ Time Frame: Baseline and 8 weeks ]
    Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
  • Change in protein expression of tumor necrosis factor [ Time Frame: Baseline and 8 weeks ]
    Tumor necrosis factor
  • cRP expression [ Time Frame: Baseline and 8 weeks ]
    c reactive protein expression
  • Change in NF-kB gene expression [ Time Frame: Baseline and 8 weeks ]
    Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
  • Change in NF-kB protein expression [ Time Frame: Baseline and 8 weeks ]
    Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
  • Change in INFG gene expression [ Time Frame: Baseline and 8 weeks ]
    Interferon gamma gene expresison
  • Change in Interferon gamma protein expression [ Time Frame: Baseline and 8 weeks ]
    Interferon gamma protein expresison
  • Mitochondrial DNA Copy Number [ Time Frame: Baseline and 8 weeks ]
    Copy number is assessed using quantitative real-time-PCR
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • Change in mindfulness skills [ Time Frame: Baseline and 8 weeks ]
    Five Factor Mindfulness Questionnaire (FFMQ)
  • Change in decentering [ Time Frame: Baseline and 8 weeks ]
    Experiences Questionaire (EQ)
  • Change in rumination [ Time Frame: Baseline and 8 weeks ]
    Rumination Response Scale (RRS)
  • Change in emotional processing bias [ Time Frame: Baseline and 8 weeks ]
    Facial Expression Recognition task (FERT)
  • Change in interoceptive awareness [ Time Frame: Baseline and 8 weeks ]
    Multidimensional Assessment of Interoceptive Awareness (MAIA)
  • Change in perceived stress [ Time Frame: Baseline and 8 weeks ]
    Perceived Stress Scale (PSS)
  • Time to relapse or recurrence of depression [ Time Frame: 12 months follow up ]
    Structured clinical interview for DSM-IV
  • Change in depressive symptoms [ Time Frame: Baseline and 8 weeks ]
    Quick Inventory for Depressive Symptomology (QIDS-SR)
  • Change in gene expression of interleukin [ Time Frame: Baseline and 8 weeks ]
    (IL-1, IL-6)
  • Change in protein expression of interleukin [ Time Frame: Baseline and 8 weeks ]
    IL-10, IL-12p70, IL-13, IL-2, IL-4, IL-8
  • Change in gene expression of norepinephrine transporter (NET) [ Time Frame: Baseline and 8 weeks ]
  • Change in protein expression of norepinephrine transporter (NET) [ Time Frame: Baseline and 8 weeks ]
  • Change in gene expression of the glutamate receptor (GRM7) [ Time Frame: Baseline and 8 weeks ]
  • Change in protein expression of the glutamate receptor (GRM7) [ Time Frame: Baseline and 8 weeks ]
  • Change in gene expression of tumor necrosis factor (TNF) [ Time Frame: Baseline and 8 weeks ]
    alpha and C reactive protein
  • Change in protein expression of tumor necrosis factor (TNF) [ Time Frame: Baseline and 8 weeks ]
    alpha and C reactive protein
Current Other Pre-specified Outcome Measures
 (submitted: December 6, 2018)
  • 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
  • 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)
Original Other Pre-specified Outcome Measures
 (submitted: November 22, 2017)
fMRI BOLD secondary and whole brain analyses [ Time Frame: Baseline and 8 weeks ]
fMRI BOLD whole brain analyses (data-driven) and secondary seed-based analyses: As seeds we select medial prefrontal cortex, insula, hippocampus, the amygdala and the dorso-lateral prefrontal cortex.
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
Official Title  ICMJE Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
Masking: Single (Outcomes Assessor)
Masking Description:
Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder, Recurrent
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: MBCT + 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.
    Interventions:
    • Behavioral: MBCT
    • Other: TAU
  • TAU
    Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
    Intervention: Other: TAU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2018)
80
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
75
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353493
Other Study ID Numbers  ICMJE 314 #2016-051-000001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anne Maj van der Velden, University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • University of Oxford
  • VIA University College
  • University of York
  • Harvard Medical School (HMS and HSDM)
Investigators  ICMJE
Principal Investigator: Anne Maj van der Velden, Msc Department of Clinical Medicine, Aarhus University.
PRS Account University of Aarhus
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP