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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
  Purpose

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 Intervention Phase
Major Depressive Disorder
Recurrent
 Behavioral: Mindfulness Based Cognitive Therapy
Behavioral: Health Enhancement Program
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of Denver:

Primary Outcome Measures:
  • Depression Relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive Symptoms [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Based Cognitive Therapy Behavioral: Mindfulness Based Cognitive Therapy
Active Comparator: Health Enhancement Program Behavioral: Health Enhancement Program

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145872

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

No publications provided

Responsible Party: Amanda Shallcross, Post-Doctoral Researcher, University of Denver
ClinicalTrials.gov Identifier: NCT01145872     History of Changes
Other Study ID Numbers: F32 AT004879-01A2
Study First Received: June 16, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Denver:
Mindfulness
clinical trial
intervention
prevention

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

ClinicalTrials.gov processed this record on May 22, 2013