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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2019-06-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Major Depressive Disorder, Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

MBCT

Intervention Type 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).

TAU

Intervention Type OTHER

Treatment as usual (TAU)

TAU

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

Group Type OTHER

TAU

Intervention Type OTHER

Treatment as usual (TAU)

Interventions

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MBCT

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 BEHAVIORAL

TAU

Treatment as usual (TAU)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No