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

NCT02314390 | Completed

• 1 other identifier: FVHH
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Symptoms

Keywords

Depression; Mindfulness; MBCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in well-being

  Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

• Change in generalized anxiety

  Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Other Outcomes (2)

• Change in mindfulness

  Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

• Change in self-compassion

  Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Study Arms (2)

G-MBCT

EXPERIMENTAL

Group-Mindfulness-Based Cognitive Therapy

Behavioral: Group-Mindfulness-Based Cognitive Therapy

I-MBCT

EXPERIMENTAL

Individual-Mindfulness-Based Cognitive Therapy

Behavioral: Individual-Mindfulness-Based Cognitive Therapy

Interventions

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.

Also known as: G-MBCT

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.

Also known as: I-MBCT

I-MBCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Robbert Sanderman, Prof.

  University Medical Center Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 11, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12