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
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
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
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
