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Completed

NCT Number: NCT02314390

Group- Versus Individual-Mindfulness-Based Cognitive Therapy: 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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group-Mindfulness-Based Cognitive Therapy

Behavioral

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: G-MBCT

Individual-Mindfulness-Based Cognitive Therapy

Behavioral

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

Other names: I-MBCT

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • University of Groningen

Registry information

Official study title

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

Acronym: G/I-MBCT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2014
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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