UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exposure Response Prevention for Obsessive Compulsive Disorder Utilizing WEB Conference System: A Feasibility Study
Title of the study (Brief title)	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	Taishiro Kishimoto
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi Shinjuku Tokyo
TEL	033353111
Email	taishiro-k@mti.biglobe.ne.jp

Public contact
Name of contact person	Taishiro Kishimoto
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi Shinjuku Tokyo
TEL	033353111
Homepage URL
Email	taishiro-k@mti.biglobe.ne.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019268