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Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial (G/I-MBCT)

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ClinicalTrials.gov Identifier: NCT02314390
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
University of Groningen
Information provided by (Responsible Party):
Maya Schroevers, 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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Group-Mindfulness-Based Cognitive Therapy Behavioral: Individual-Mindfulness-Based Cognitive Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G-MBCT
Group-Mindfulness-Based Cognitive Therapy
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.
Other Name: G-MBCT

Experimental: I-MBCT
Individual-Mindfulness-Based Cognitive Therapy
Behavioral: 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 Name: I-MBCT




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)


Other Outcome Measures:
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314390


Sponsors and Collaborators
University Medical Center Groningen
University of Groningen
Investigators
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Study Chair: Robbert Sanderman, Prof. University Medical Center Groningen

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Responsible Party: Maya Schroevers, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02314390     History of Changes
Other Study ID Numbers: FVHH
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Maya Schroevers, University Medical Center Groningen:
Depression
Mindfulness
MBCT

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms