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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02314390
Acronym
G/I-MBCT
Enrollment
56
Registered
2014-12-11
Start date
2013-09-30
Completion date
2014-08-31
Last updated
2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms

Keywords

Depression, Mindfulness, MBCT

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.

Interventions

BEHAVIORALGroup-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.

BEHAVIORALIndividual-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.

Sponsors

University of Groningen
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in severity of depressive symptomsPre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-upSeverity of depressive symptoms are assessed with the Beck Depression Inventory-II

Secondary

MeasureTime frameDescription
Change in well-beingPre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-upWell-being is measured by the Well-being Index (WHO-5)
Change in generalized anxietyPre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-upGeneralized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)

Other

MeasureTime frameDescription
Change in mindfulnessPre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-upMindfulness is assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Change in self-compassionPre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-upSelf-compassion is assessed with the 12 item Self-Compassion Scales

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026