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

Depressive Symptoms Clinical Trial

— G/I-MBCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314390
• Other study ID #: FVHH
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: December 8, 2014
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Symptoms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	University of Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mindfulness	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	No
Other	Change in self-compassion	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No