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

NCT03353493 | Completed

• 1 other identifier: 314 #2016-051-000001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder, Recurrent

Keywords

Mindfulness-Based Cognitive Therapy; Neural, psychological and molecular mechanisms

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 8 weeks

Secondary Outcomes (20)

• Change in mindfulness skills

  Baseline and 8 weeks

• Change in decentering

  Baseline and 8 weeks

• Change in rumination

  Baseline and 8 weeks

• Change in emotional processing bias

  Baseline and 8 weeks

• Change in interoceptive awareness

  Baseline and 8 weeks

Other Outcomes (2)

• fMRI BOLD secondary and whole brain analyses

  Baseline and 8 weeks

• Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.

  Baseline and 8 weeks

Study Arms (2)

MBCT + TAU

EXPERIMENTAL

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; Other: TAU

TAU

OTHER

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

Other: TAU

Interventions

MBCT BEHAVIORAL

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).

MBCT + TAU

TAU OTHER

Treatment as usual (TAU)

MBCT + TAU; TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Oxford: collaborator
• VIA University College: collaborator
• University of York: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (1)

• van der Velden AM, Scholl J, Elmholdt EM, Fjorback LO, Harmer CJ, Lazar SW, O'Toole MS, Smallwood J, Roepstorff A, Kuyken W. Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial. Biol Psychiatry. 2023 Feb 1;93(3):233-242. doi: 10.1016/j.biopsych.2022.06.038. Epub 2022 Jul 22.

  PMID: 36328822 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Maj van der Velden, Msc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Model Details: Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: November 27, 2017
• Study Start: February 15, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)