NCT02006199

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 14, 2016

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

December 4, 2013

Last Update Submit

October 12, 2016

Conditions

Obsessive-compulsive Disorder

Keywords

obsessive-compulsive disordermindfulnessmeditation

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive compulsive scores

    8 weeks

Secondary Outcomes (1)

  • Neurocognitive profile (emotion-memory task)

    8 weeks

Other Outcomes (1)

  • HAM-D

    8 weeks

Study Arms (2)

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

mindfulness meditationBEHAVIORAL

8 weeks of mindfulness meditation specified for OCD patient

meditationrelaxation with psychoeducation

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • obsessive-compulsive disorder
  • age 17-55

You may not qualify if:

  • currently undergoing Cognitive Behavioral Therapy, psychotherapy
  • other medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jun Soo Kwon, MD phD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 14, 2016

Record last verified: 2013-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)