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NCT Number: NCT01145872

The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Disease Attributes Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Denver

Denver, Colorado, 80208, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

Health Enhancement Program

Behavioral

Primary outcomes

  1. Depression Relapse

    Time frame: 1 year

Secondary outcomes

  1. Depressive Symptoms

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

University of Denver

Other

Collaborators

  • Stanford University
  • University of Colorado, Boulder

Registry information

Official study title

The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse

Acronym: MBCT

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 17, 2010
Registry last updated
Dec 2, 2014

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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