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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Denver.
Recruitment status was  Active, not recruiting
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

June 16, 2010
June 12, 2012
July 2010
May 2012   (final data collection date for primary outcome measure)
Depression Relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01145872 on ClinicalTrials.gov Archive Site
Depressive Symptoms [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Major Depressive Disorder
  • Recurrent
  • Behavioral: Mindfulness Based Cognitive Therapy
  • Behavioral: Health Enhancement Program
  • Experimental: Mindfulness Based Cognitive Therapy
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • Active Comparator: Health Enhancement Program
    Intervention: Behavioral: Health Enhancement Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
April 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145872
F32 AT004879-01A2
Yes
Amanda Shallcross, University of Denver
University of Denver
  • Stanford University
  • University of Colorado, Boulder
Not Provided
University of Denver
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP