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

Major Depressive Disorder Clinical Trial

— MBCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145872
• Other study ID #: F32AT004879-01A2
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2010
• Last updated: December 1, 2014
• Start date: July 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: University of Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Recurrent

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy

• Health Enhancement Program

Locations

Country	Name	City	State
United States	University of Denver	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Denver	Stanford University, University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Relapse		1 year	No
Secondary	Depressive Symptoms		1 Year	No