UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016604
Receipt number R000019268
Scientific Title Exposure Response Prevention for Obsessive Compulsive Disorder Utilizing WEB Conference System: A Feasibility Study
Date of disclosure of the study information 2015/02/23
Last modified on 2018/02/28 09:42:37

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Basic information

Public title

Exposure Response Prevention for Obsessive Compulsive Disorder Utilizing WEB Conference System: A Feasibility Study

Acronym

Remote Exposure Response Prevention for Obsessive Compulsive Disorder

Scientific Title

Exposure Response Prevention for Obsessive Compulsive Disorder Utilizing WEB Conference System: A Feasibility Study

Scientific Title:Acronym

Remote Exposure Response Prevention for Obsessive Compulsive Disorder

Region

Japan North America


Condition

Condition

Obsessive Compulsive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is a pilot study which utilizes WEB communicating technology to deliver Exposure Response Prevention (EXRP). Some patients cannot receive EXRP due to lack of accessibility of EXRP trained clinicians or OCD symptomatolgy that confines them to their home and prevents an in-person visit to a clinician. Moreover, OCD symptoms can be more severe in their home environment, therefore internet therapy which brings therapist into the home may be more beneficial for many patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

patients acceptability

Key secondary outcomes

technological issue, effectiveness, safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Exposure Response Prevention (EXRP) utilizing telemedicine

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

i) Adult patients meeting OCD diagnoses by DSM-5, 8 to 23 point by Yale-Brown Obsessive-Compulsive Scale (YBOCS) score
ii) Patients at Keio University Hospital and other study sites, having been seen for 2 months or longer and on stable dose of medication or off medication.
iii) Judged by treating clinician that EXRP is appropriate and remote EXRP can be applied.
iv) Patients who desire to receive EXRP and not decisionally impaired.
v) have internet access at their home and can use internet or can get assist by caregivers

Key exclusion criteria

Clinical diagnoses of other major psychiatric disorders, such as major depressive disorder, bipolar disorder, pervasive developmental disorder, mental retardation. Severe somatic disease that prevent from receiving EXRP.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taishiro Kishimoto

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address

35 Shinanomachi Shinjuku Tokyo

TEL

033353111

Email

taishiro-k@mti.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taishiro Kishimoto

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address

35 Shinanomachi Shinjuku Tokyo

TEL

033353111

Homepage URL


Email

taishiro-k@mti.biglobe.ne.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Pfizer health research and self funding

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 05 Month 29 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 23 Day

Last modified on

2018 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name