Clinical trial NCT03353493: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder, Recurrent
Keywords: Mindfulness-Based Cognitive Therapy
Neural, psychological and molecular mechanisms
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: VIA University College
name: University of York
name: Harvard Medical School (HMS and HSDM)
First posted: 2017-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
Primary purpose: BASIC_SCIENCE

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

Eligibility 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.

Primary outcomes:
measure: Change in neural connectivity
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in mindfulness skills
timeFrame: Baseline and 8 weeks
measure: Change in decentering
timeFrame: Baseline and 8 weeks
measure: Change in rumination
timeFrame: Baseline and 8 weeks
measure: Change in emotional processing bias
timeFrame: Baseline and 8 weeks
measure: Change in interoceptive awareness
timeFrame: Baseline and 8 weeks
measure: Change in perceived stress
timeFrame: Baseline and 8 weeks
measure: Time to relapse or recurrence of depression
timeFrame: 12 months follow up
measure: Change in depressive symptoms
timeFrame: Baseline and 8 weeks
measure: Change in interleukin gene expression
timeFrame: Baseline and 8 weeks
measure: Change in interleukin protein expression
timeFrame: Baseline and 8 weeks
measure: Change in gene expression of norepinephrine transporter
timeFrame: Baseline and 8 weeks
measure: Change in gene expression of glutamate receptor
timeFrame: Baseline and 8 weeks
measure: Change in gene expression of TNF
timeFrame: Baseline and 8 weeks
measure: Change in protein expression of tumor necrosis factor
timeFrame: Baseline and 8 weeks
measure: cRP expression
timeFrame: Baseline and 8 weeks
measure: Change in NF-kB gene expression
timeFrame: Baseline and 8 weeks
measure: Change in NF-kB protein expression
timeFrame: Baseline and 8 weeks
measure: Change in INFG gene expression
timeFrame: Baseline and 8 weeks
measure: Change in Interferon gamma protein expression
timeFrame: Baseline and 8 weeks
measure: Mitochondrial DNA Copy Number
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: fMRI BOLD secondary and whole brain analyses
timeFrame: Baseline and 8 weeks
measure: Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.
timeFrame: Baseline and 8 weeks
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Anne Maj van der Velden, Msc
role: PRINCIPAL_INVESTIGATOR
References: