UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048120 |
|---|---|
| Receipt number | 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 | 2022/12/27 09:46:57 |
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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
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
ihits@hotmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
3
Results
Three patients participated in the study. The OCD symptoms and depression improved in all the patients(Y-BOCS 21 to 16, 21 to 6, 18 to 13; OCI 46 to 18, 23 to 14, 40 to 27; PHQ-9 4 to 1, 12 to 3, 16 to 10). The symptoms of anxiety did not change or worsen (OASIS 4 to 4, 2 to 3, 7 to 7). The sessions completed were 10 (25%), 19 (47.5%), 13 (32.5%).
Results date posted
| 2022 | Year | 12 | Month | 27 | Day |
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
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
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
| 2022 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054842
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