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

Study Overview
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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.

Official Title
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Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Group-Mindfulness-Based Cognitive Therapy
* Behavioral: Individual-Mindfulness-Based Cognitive Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-MBCT<br>Group-Mindfulness-Based Cognitive Therapy | Behavioral: Group-Mindfulness-Based Cognitive Therapy<br>* The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.<br>* Other names: G-MBCT;|
| Experimental: I-MBCT<br>Individual-Mindfulness-Based Cognitive Therapy | Behavioral: Individual-Mindfulness-Based Cognitive Therapy<br>* The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.<br>* Other names: I-MBCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of depressive symptoms | Severity of depressive symptoms are assessed with the Beck Depression Inventory-II | Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in well-being | Well-being is measured by the Well-being Index (WHO-5) | 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) | Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Mindfulness, MBCT