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Completed

NCT Number: NCT01038765

Mindfulness Based Cognitive Therapy for Recurrent Depression

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

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525 GC, Netherlands

About this study

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:

  • to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
  • to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

8-weeks group based intervention of mindfulness and cognitive behavioural techniques

Other names: MBCT

Primary outcomes

  1. Depressive Symptoms

    Time frame: 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 outcomes

  1. Self-report Depressive Symptoms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Fonds Psychische Gezondheid

Registry information

Official study title

Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Dec 24, 2009
Registry last updated
Jan 30, 2024

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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