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Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial

NCT ID: NCT02314390

Last Updated: 2014-12-11

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to determine whether both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease.

Detailed Description

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Depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. In recent years, Mindfulness-Based Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. Usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of MBCT as an individual training.

This pilot study aims to compare the effectiveness and feasibility of group and individual MBCT in reducing depressive symptoms in patients with a chronic somatic disease.

Conditions

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Depressive Symptoms

Keywords

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Depression Mindfulness MBCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G-MBCT

Group-Mindfulness-Based Cognitive Therapy

Group Type EXPERIMENTAL

Group-Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.

I-MBCT

Individual-Mindfulness-Based Cognitive Therapy

Group Type EXPERIMENTAL

Individual-Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

Interventions

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Group-Mindfulness-Based Cognitive Therapy

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.

Intervention Type BEHAVIORAL

Individual-Mindfulness-Based Cognitive Therapy

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

Intervention Type BEHAVIORAL

Other Intervention Names

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G-MBCT I-MBCT

Eligibility Criteria

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Inclusion Criteria

* Chronic somatic disease
* Age ≥ 18 and ≤ 70
* Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)

Exclusion Criteria

* Not being able to read and write Dutch
* Severe (psychiatric) co-morbidity
* Acute suicidal ideations or behavior
* Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study

Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Groningen

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Maya Schroevers

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robbert Sanderman, Prof.

Role: STUDY_CHAIR

University Medical Center Groningen

Other Identifiers

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FVHH

Identifier Type: -

Identifier Source: org_study_id