Effect of Mindfulness Based Treatment for Obsessive-compu... | NCT02006199

Studies
Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder

NCT02006199

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Oct 14, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Obsessive-compulsive Disorder

Interventions

mindfulness meditation

Countries

South Korea

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawal of the administrative reason

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Dec 4, 2013

First Submission Date that Met QC Criteria

Dec 4, 2013

First Posted Date

Dec 10, 2013Estimated

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

Oct 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

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

Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.

Detailed Description

Before and after 8 weeks of mindfulness program, We will measure Y-BOCS scores in OCD patients. As a control program, relaxation and psychoeducation will provided to OCD patients.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
relaxation with psychoeducation	Experimental	after 8 weeks of relaxation with psychoeducation. subject take part in 8 weeks of the mindfulness meditation program	Behavioral: mindfulness meditation
meditation	Experimental	8 weeks of mindfulness meditation	Behavioral: mindfulness meditation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mindfulness meditation	Behavioral	8 weeks of mindfulness meditation specified for OCD patient	meditation relaxation with psychoeducation

Measure	Description	Time Frame
Yale-Brown Obsessive compulsive scores		8 weeks

Measure	Description	Time Frame
Neurocognitive profile (emotion-memory task)		8 weeks

Measure	Description	Time Frame
HAM-D		8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obsessive-compulsive disorder
age 17-55

Exclusion Criteria:

currently undergoing Cognitive Behavioral Therapy, psychotherapy
other medical disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Soo Kwon, MD phD	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064866	Mindfulness

Ancestor Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided