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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048120
Receipt No. R000054842
Scientific Title Efficacy and feasibility of software for the treatment of obsessive compulsive disorder: a pilot study
Date of disclosure of the study information 2022/06/21
Last modified on 2022/06/21

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Basic information
Public title Efficacy and feasibility of software for the treatment of obsessive compulsive disorder: a pilot study
Acronym Efficacy and feasibility of software for the treatment of obsessive compulsive disorder: a pilot study
Scientific Title Efficacy and feasibility of software for the treatment of obsessive compulsive disorder: a pilot study
Scientific Title:Acronym Efficacy and feasibility of software for the treatment of obsessive compulsive disorder: a pilot study
Region
Japan

Condition
Condition Obsessive compulsive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the efficacy and feasibility of software for the treatment of obsessive compulsive disorder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Yale-Brown Obsessive Compulsive Scale(Y-BOCS) at 8 wks, dropouts for any reason at 8wks
Key secondary outcomes Patient Health Questionnaire(PHQ-9), Overall Anxiety Severity and Impairment Scale (OASIS), Obsessive-Compulsive Inventory-Revised (OCI-R), Alliance with Software: AS, free description about the software and the treatment at 8wks

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 the software for the treatment of obsessive compulsive disorder for up to 8 wks
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 Patients with obsessive compulsive disorder diagnosed by DSM-5.
Key exclusion criteria High risk of suicide, self-harm, admission. Those who cannnot answer the questionnaire du to the lack of ability. Those who don't have computer or smartphone. Those who have received CBT or those who will receive CBT during this trial.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Toshiaki
Middle name A
Last name Furukawa
Organization Kyoto University
Division name Health Promotion and Human Behavior, Graduate School of Medicine / School of Public Health
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL +81-75-753-9491
Email ihits@hotmail.com

Public contact
Name of contact person
1st name Hissei
Middle name
Last name Imai
Organization Kyoto University
Division name Health Promotion and Human Behavior, Graduate School of Medicine / School of Public Health
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL +81-75-753-9491
Homepage URL
Email ihits@hotmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research (KAKENHI)
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2022 Year 06 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2022 Year 07 Month 07 Day
Last follow-up date
2022 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 21 Day
Last modified on
2022 Year 06 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054842

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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