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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016604
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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