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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Stanford University

University of Colorado, Boulder

Information provided by (Responsible Party):

Amanda Shallcross, University of Denver

ClinicalTrials.gov Identifier:

NCT01145872

First received: June 16, 2010

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 16, 2010
Last Updated Date	June 12, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Depression Relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01145872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Depressive Symptoms [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
Official Title ^ICMJE	The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Major Depressive Disorder Recurrent
Intervention ^ICMJE	Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Health Enhancement Program
Study Arm (s)	Experimental: Mindfulness Based Cognitive Therapy Intervention: Behavioral: Mindfulness Based Cognitive Therapy Active Comparator: Health Enhancement Program Intervention: Behavioral: Health Enhancement Program
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	64
Estimated Completion Date	April 2013
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01145872
Other Study ID Numbers ^ICMJE	F32 AT004879-01A2
Has Data Monitoring Committee	Yes
Responsible Party	Amanda Shallcross, University of Denver
Study Sponsor ^ICMJE	University of Denver
Collaborators ^ICMJE	Stanford University University of Colorado, Boulder
Investigators ^ICMJE	Not Provided
Information Provided By	University of Denver
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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