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

Primary Purpose

Major Depressive Disorder, Recurrent

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Health Enhancement Program
Sponsored by
University of Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depressive Disorder focused on measuring Mindfulness, clinical trial, intervention, prevention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Cognitive Therapy

Health Enhancement Program

Arm Description

Outcomes

Primary Outcome Measures

Depression Relapse

Secondary Outcome Measures

Depressive Symptoms

Full Information

First Posted
June 16, 2010
Last Updated
December 1, 2014
Sponsor
University of Denver
Collaborators
Stanford University, University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT01145872
Brief Title
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
Acronym
MBCT
Official Title
The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Denver
Collaborators
Stanford University, University of Colorado, Boulder

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Recurrent
Keywords
Mindfulness, clinical trial, intervention, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Experimental
Arm Title
Health Enhancement Program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Health Enhancement Program
Primary Outcome Measure Information:
Title
Depression Relapse
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80208
Country
United States

12. IPD Sharing Statement

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

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