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Trial record 4 of 2660 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse (MBCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01145872
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : December 2, 2014
Stanford University
University of Colorado, Boulder
Information provided by (Responsible Party):
Amanda Shallcross, University of Denver

Brief Summary:
This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates. However, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of MBCT to an active control condition (ACC). The use of a well-designed ACC will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT on depressive symptoms and relapse. Theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim 2). Collectively, these aims are expected to strengthen the evidence base for MBCT while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Recurrent Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Health Enhancement Program Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse
Study Start Date : July 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mindfulness Based Cognitive Therapy Behavioral: Mindfulness Based Cognitive Therapy
Active Comparator: Health Enhancement Program Behavioral: Health Enhancement Program

Primary Outcome Measures :
  1. Depression Relapse [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • must comprehend English well
  • be 18-55 years of age
  • meet enhanced DSM-IV criteria for remission of MDD, recurrent and have a history of three or more previous episodes of DSM-IV major depression in the absence of a history of mania or hypomania
  • at least one of those episodes was within the past two years
  • participant must be in remission and if on antidepressant medication (ADM), they must be on a stable dose with no change in type or amount for past 12 weeks or participants must be off ADM at T1 for at least the preceding 12 weeks
  • have, at screening assessment, residual depressive symptoms indicated by a Beck Depression Inventory-II (BDI-II;[72]) score between 6-19.

Exclusion Criteria:

  • bipolar disorder
  • schizophrenia or borderline personality disorder
  • current suicidal thoughts and/or suicide attempt in last two months
  • current anxiety disorder if it constitutes the predominant aspect of the clinical presentation and requires primary treatment not offered in the project
  • substance abuse or dependence within last three months
  • dementia or subnormal intellectual potential
  • current obsessive-compulsive disorder
  • current eating disorder
  • history of previous mindfulness training or more than eight lifetime sessions of CBT
  • current use of psychotherapy or counseling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01145872

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United States, Colorado
University of Denver
Denver, Colorado, United States, 80208
Sponsors and Collaborators
University of Denver
Stanford University
University of Colorado, Boulder

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Responsible Party: Amanda Shallcross, Post-Doctoral Researcher, University of Denver Identifier: NCT01145872     History of Changes
Other Study ID Numbers: F32AT004879-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Amanda Shallcross, University of Denver:
clinical trial

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders