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

Primary Purpose

Major Depressive Disorder, Recurrent

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MBCT
TAU
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder, Recurrent focused on measuring Mindfulness-Based Cognitive Therapy, Neural, psychological and molecular mechanisms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MBCT + TAU

TAU

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2017
Last Updated
June 4, 2019
Sponsor
University of Aarhus
Collaborators
University of Oxford, VIA University College, University of York, Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT03353493
Brief Title
Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
University of Oxford, VIA University College, University of York, Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Recurrent
Keywords
Mindfulness-Based Cognitive Therapy, Neural, psychological and molecular mechanisms

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
Masking
Outcomes Assessor
Masking Description
Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT + TAU
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Other
Arm Description
Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
Intervention Type
Behavioral
Intervention Name(s)
MBCT
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
Treatment as usual (TAU)
Primary Outcome Measure Information:
Title
Change in neural connectivity
Description
Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in mindfulness skills
Description
Five Factor Mindfulness Questionnaire (FFMQ)
Time Frame
Baseline and 8 weeks
Title
Change in decentering
Description
Experiences Questionaire (EQ)
Time Frame
Baseline and 8 weeks
Title
Change in rumination
Description
Rumination Response Scale (RRS)
Time Frame
Baseline and 8 weeks
Title
Change in emotional processing bias
Description
Facial Expression Recognition task (FERT)
Time Frame
Baseline and 8 weeks
Title
Change in interoceptive awareness
Description
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame
Baseline and 8 weeks
Title
Change in perceived stress
Description
Perceived Stress Scale (PSS)
Time Frame
Baseline and 8 weeks
Title
Time to relapse or recurrence of depression
Description
Structured clinical interview for DSM-IV
Time Frame
12 months follow up
Title
Change in depressive symptoms
Description
Quick Inventory for Depressive Symptomology (QIDS-SR)
Time Frame
Baseline and 8 weeks
Title
Change in interleukin gene expression
Description
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Time Frame
Baseline and 8 weeks
Title
Change in interleukin protein expression
Description
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Time Frame
Baseline and 8 weeks
Title
Change in gene expression of norepinephrine transporter
Description
Norepinephrine transporter (NET)
Time Frame
Baseline and 8 weeks
Title
Change in gene expression of glutamate receptor
Description
Glutamate receptor (GRM7)
Time Frame
Baseline and 8 weeks
Title
Change in gene expression of TNF
Description
Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
Time Frame
Baseline and 8 weeks
Title
Change in protein expression of tumor necrosis factor
Description
Tumor necrosis factor
Time Frame
Baseline and 8 weeks
Title
cRP expression
Description
c reactive protein expression
Time Frame
Baseline and 8 weeks
Title
Change in NF-kB gene expression
Description
Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
Time Frame
Baseline and 8 weeks
Title
Change in NF-kB protein expression
Description
Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
Time Frame
Baseline and 8 weeks
Title
Change in INFG gene expression
Description
Interferon gamma gene expresison
Time Frame
Baseline and 8 weeks
Title
Change in Interferon gamma protein expression
Description
Interferon gamma protein expresison
Time Frame
Baseline and 8 weeks
Title
Mitochondrial DNA Copy Number
Description
Copy number is assessed using quantitative real-time-PCR
Time Frame
Baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
fMRI BOLD secondary and whole brain analyses
Description
fMRI BOLD whole brain analyses (data-driven) and secondary subcortical seed-based analyses: As seeds we preselect hippocampus, the amygdala and striatum
Time Frame
Baseline and 8 weeks
Title
Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.
Description
HG-U133 Plus 2.0 GeneChip (Affymetrix)
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Maj van der Velden, Msc
Organizational Affiliation
Department of Clinical Medicine, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://interactingminds.au.dk/projects/mindfulness-and-the-prevention-of-depression/
Description
Study website

Learn more about this trial

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

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