Study of Mindfulness-Based Cognitive Therapy | NCT00943033

Studies
Study of Mindfulness-Based Cognitive Therapy

NCT00943033

Sponsor

Binghamton University

Status

Completed

Last Update Posted

Sep 21, 2012Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jul 13, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2012

Last Update Posted Date

Sep 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Research aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness-Based Cognitive Therapy plus treatment as usual	Experimental		Behavioral: Mindfulness-Based Cognitive Therapy
MBCT Waitlist plus Treatment as Usual	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Cognitive Therapy	Behavioral	Mindfulness-Based Cognitive Therapy for the prevention of depressive relapse/recurrence	Mindfulness-Based Cognitive Therapy plus treatment as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sustained Attention to Response Task		zero to four weeks pre-treatment and zero to three weeks post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Five Facet Mindfulness Questionnaire		zero to four weeks pre-treatment and zero to three weeks post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year
Can speak, read, and understand English

Exclusion Criteria:

Meet Criteria for Current Major Depressive Episode or are in partial remission
BDI-II score above 19
Abuse alcohol or drugs
Current Dysthymic Disorder
History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean M. Barnes, MS	Binghamton University SUNY	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000099025	Mindfulness-Based Cognitive Therapy

Ancestor Terms

ID	Term
D064866	Mindfulness
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided