Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change in neural connectivity
Study 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TAU
Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
Intervention: TAU (Other)
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.
Intervention: TAU (Other)
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.
Intervention: MBCT (Behavioral)
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)
Investigators
Anne Maj van der Velden
PhD fellow
University of Aarhus