Obsessive-compulsive DisorderNCT02006199
Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder
A study testing mindfulness meditation in people with Obsessive-compulsive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms. Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- obsessive-compulsive disorder
- age 17-55
Who cannot join
- currently undergoing Cognitive Behavioral Therapy, psychotherapy
- other medical disease
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.
Read the 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.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- mindfulness meditation
- Keywords
- obsessive-compulsive disorder, mindfulness, meditation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness meditationBehavioural
8 weeks of mindfulness meditation specified for OCD patient
| Study group | Role | What they receive |
|---|---|---|
| relaxation with psychoeducation | Experimental | after 8 weeks of relaxation with psychoeducation. subject take part in 8 weeks of the mindfulness meditation program Receives: Behavioral: mindfulness meditation |
| meditation | Experimental | 8 weeks of mindfulness meditation Receives: Behavioral: mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive compulsive scores
Measured: 8 weeks
Secondary outcomes (1)
Neurocognitive profile (emotion-memory task)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: Withdrawal of the administrative reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Soo Kwon, MD phD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006199
- Sponsor's protocol ID
- 1306-076-498
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02006199
- Acronym / sponsor ID
- 1306-076-498
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- obsessive-compulsive disorder, mindfulness, meditation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of the administrative reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| relaxation with psychoeducation | Experimental | Behavioral: mindfulness meditationafter 8 weeks of relaxation with psychoeducation. subject take part in 8 weeks of the mindfulness meditation program |
| meditation | Experimental | Behavioral: mindfulness meditation8 weeks of mindfulness meditation |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- obsessive-compulsive disorder
- age 17-55
Key exclusion criteria (2 listed)
- currently undergoing Cognitive Behavioral Therapy, psychotherapy
- other medical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness meditation8 weeks of mindfulness meditation specified for OCD patient | Behavioural | meditation, relaxation with psychoeducation |
Primary outcome
Yale-Brown Obsessive compulsive scores
Time frame: 8 weeks
1 secondary outcome
Neurocognitive profile (emotion-memory task)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Obsessive-compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Soo Kwon, MD phD principal investigator
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness meditation in people with Obsessive-compulsive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive compulsive scores (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.