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

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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
Information provided by (Responsible Party):
Anne Maj van der Velden, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder, Recurrent Behavioral: MBCT Other: TAU Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
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
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)

TAU
Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
Other: TAU
Treatment as usual (TAU)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353493


Locations
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Denmark
Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
University of Oxford
VIA University College
University of York
Harvard Medical School
Investigators
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Principal Investigator: Anne Maj van der Velden, Msc Department of Clinical Medicine, Aarhus University.
Additional Information:
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Responsible Party: Anne Maj van der Velden, PhD fellow, University of Aarhus
ClinicalTrials.gov Identifier: NCT03353493    
Other Study ID Numbers: 314 #2016-051-000001
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Maj van der Velden, University of Aarhus:
Mindfulness-Based Cognitive Therapy
Neural, psychological and molecular mechanisms
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms