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Completed

NCT Number: NCT00183560

Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Joseph's Healthcare, Hamilton, Ontario, Canada

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About this study

Depression is a serious condition that can cause significant social and emotional problems and reduce the overall quality of life. Relapses in depressive episodes are common and may result in a patient's reluctance to follow a treatment regimen, thus making the episode more severe. Safe and effective therapies to prevent depression relapse are needed. This study will compare three different approaches to determine which is most effective in preventing relapses in depressive episodes.

This study will comprise 2 parts. In Part 1, all participants will receive antidepressant medication for 6 months. Participants whose depression symptoms do not improve will complete their study participation at the end of Part 1. Participants who respond to their regimen will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will be randomly assigned to one of three groups. Participants in Group 1 will continue the drug regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants and attend an 8-week relapse prevention program. This MBCT program is designed to help participants learn skills that can increase their awareness and change their reaction to stressful events. Participants in Group 3 will have their antidepressant medication from Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to assess the depressive symptoms of participants at the beginning of the study, at the end of Phase 1, and at the end of the study, after Phase 2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet DSM criteria for recurrent major depressive disorder, defined as at least one major depressive episode within 3 years prior to study entry AND at least 2 months of normal functioning following the episode

Exclusion criteria

  • Depression secondary to a concurrent medical disorder
  • Current use of medication that could cause depressive symptoms
  • A rating of level 2 or higher on the Index of Treatment Refractory Depression
  • Current diagnosis of any of the following psychiatric disorders: psychotic or organic mental, bipolar, primary obsessive compulsive, borderline personality, antisocial personality, or eating
  • Current diagnosis of comorbid chronic depression that is disabling
  • Current substance abuse
  • Score less than 14 on the Hamilton Rating Scale for Depression-17 (HRSD-17)
  • At risk for suicide
  • Pregnancy or plan to become pregnant during the study
  • Practice meditation more than once a week or yoga more than twice a week at study entry

Treatment and study plan

Mindfulness Based Cognitive Therapy (MBCT)

Behavioral

Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.

Other names: MBCT

Antidepressants

Drug

Participants continue on dosage of the antidepressant that was used to achieve clinical remission.

Other names: Antidepressant medication

Placebo plus clinical management

Drug

Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.

Other names: Placebo and Clinical Management

Primary outcomes

  1. Relapse of depression

    Time frame: Measured at Month 18

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Prevention of Relapse in Recurrent Depression With MBCT

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Jul 1, 2015

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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