Mindfulness Based Cognitive Therapy for Recurrent Depression

Not Applicable

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy

• Registration Number: NCT01038765
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Detailed Description

Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.

Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.

Study aims are:

1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention

2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms

3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment

In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2010-03
• Study Completion: 2011-01
• Results First Submitted: 2021-01-25
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 3 or more previous depressive episodes
• if treated with medication: constant dose of at least 6 weeks

Exclusion Criteria

• Bipolar Disorder
• Psychotic disorder
• Neurological or somatic illness affecting depression or outcome measures
• Current alcohol or drugs dependency
• Acute need of psychiatric treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Cognitive Therapy	Mindfulness Based Cognitive Therapy	Mindfulness Based Cognitive Therapy

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.	Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score.; Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).

Secondary Outcome Measures

Name	Time	Method
Self-report Depressive Symptoms	Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis	Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63.; Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63).

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands