Skip to main content
Clinical Trials/NCT03353493
NCT03353493
Completed
N/A

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

University of Aarhus1 site in 1 country80 target enrollmentFebruary 15, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Major Depressive Disorder, Recurrent
Sponsor
University of Aarhus
Enrollment
80
Locations
1
Primary Endpoint
Change in neural connectivity
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 15, 2017
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Maj van der Velden

PhD fellow

University of Aarhus

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.

Outcomes

Primary Outcomes

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

  • Change in perceived stress(Baseline and 8 weeks)
  • Change in decentering(Baseline and 8 weeks)
  • Time to relapse or recurrence of depression(12 months follow up)
  • Mitochondrial DNA Copy Number(Baseline and 8 weeks)
  • Change in interleukin gene expression(Baseline and 8 weeks)
  • Change in emotional processing bias(Baseline and 8 weeks)
  • cRP expression(Baseline and 8 weeks)
  • Change in INFG gene expression(Baseline and 8 weeks)
  • Change in depressive symptoms(Baseline and 8 weeks)
  • Change in gene expression of glutamate receptor(Baseline and 8 weeks)
  • Change in mindfulness skills(Baseline and 8 weeks)
  • Change in rumination(Baseline and 8 weeks)
  • Change in protein expression of tumor necrosis factor(Baseline and 8 weeks)
  • Change in NF-kB gene expression(Baseline and 8 weeks)
  • Change in interoceptive awareness(Baseline and 8 weeks)
  • Change in interleukin protein expression(Baseline and 8 weeks)
  • Change in gene expression of norepinephrine transporter(Baseline and 8 weeks)
  • Change in gene expression of TNF(Baseline and 8 weeks)
  • Change in NF-kB protein expression(Baseline and 8 weeks)
  • Change in Interferon gamma protein expression(Baseline and 8 weeks)

Study Sites (1)

Loading locations...

Similar Trials