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

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: Individual-Mindfulness-Based Cognitive Therapy; Behavioral: Group-Mindfulness-Based Cognitive Therapy

• Registration Number: NCT02314390
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

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 Timeline

• Study Start: 2013-09
• Primary Completion: 2014-03
• Study Completion: 2014-08
• Status Verified: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Study First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-MBCT	Individual-Mindfulness-Based Cognitive Therapy	Individual-Mindfulness-Based Cognitive Therapy
G-MBCT	Group-Mindfulness-Based Cognitive Therapy	Group-Mindfulness-Based Cognitive Therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in generalized anxiety	Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up	Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Change in well-being	Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up	Well-being is measured by the Well-being Index (WHO-5)