Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial (G/I-MBCT)
December 8, 2014 updated by: Maya Schroevers, University Medical Center Groningen
Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: G-MBCT
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.
Other Names:
|
|
Experimental: I-MBCT
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in severity of depressive symptoms
Time Frame: 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
|
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
Time Frame: 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)
|
Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
|
Change in generalized anxiety
Time Frame: 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)
|
Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mindfulness
Time Frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
Mindfulness is assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
|
Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
|
Change in self-compassion
Time Frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
Self-compassion is assessed with the 12 item Self-Compassion Scales
|
Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Robbert Sanderman, Prof., University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
December 1, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FVHH
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