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

University Medical Center Groningen56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depressive Symptoms

Interventions

Group-Mindfulness-Based Cognitive TherapyBEHAVIORAL

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

Individual-Mindfulness-Based Cognitive TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in severity of depressive symptoms

Severity of depressive symptoms are assessed with the Beck Depression Inventory-II

Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Secondary Outcomes

Change in well-being

Well-being is measured by the Well-being Index (WHO-5)

Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Change in generalized anxiety

Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)

Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Data from ClinicalTrials.gov

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