UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038828 |
|---|---|
| Receipt number | R000044275 |
| Scientific Title | Behavioral therapy using virtual reality for obsessive-compulsive disorder: a feasibility study |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2022/12/12 09:45:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Behavioral therapy using virtual reality for obsessive-compulsive disorder: a feasibility study
Acronym
Behavioral therapy using virtual reality for obsessive-compulsive disorder: a feasibility study
Scientific Title
Behavioral therapy using virtual reality for obsessive-compulsive disorder: a feasibility study
Scientific Title:Acronym
Behavioral therapy using virtual reality for obsessive-compulsive disorder: a feasibility study
Region
| Japan |
Condition
Condition
1. Obsessive-compulsive disorder
2. Healthy volunteers
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of behaviral therapy using virtual reality for patients with obsessive-compulsive disorder and matched healthy volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of intrinsic motivation scale.
Key secondary outcomes
Provoked obsessive-compulsive symptoms and adverse events such as simulator sickness.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Behavioral therapy using virtual reality, 1 session, for patients with obsessive-compulsive disorder.
Interventions/Control_2
Behavioral therapy using virtual reality, 1 session, for healthy volunteers.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for patients (n=10) were as follows.
(1) Patients with obsessive-compulsive disorder treated at University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan.
(2) Paients have contamination obsession and washing compulsion assessed by Yale-Brown obsessive-compulsive scale symptom checklist.
(3) Not having current or past diagnosis of psychiatric diseases and significant physical disease except obsessive-compulsive and related disorders, depressive disorders, anxiety disorders, autism spectrum disorders, tic disorders, and attentin-deficit/hyperactivity disorder.
(4) The ability to give written, informed consent after receiving a complete description of the study.
The inclusion criteria for healthy controls (n=10) were as follows.
(1) Healthy controls matched for age and sex participated in this study without current or past diagnosis of psychiatric diseases and significant physical disease assessd by Structured Clinical Interview for DSM-IV Axis I Disorders, Non-patient Edition (SCID-NP).
(2) Obsessive-compulsive inventory score is less than 41
(3) The ability to give written, informed consent after receiving a complete description of the study.
Key exclusion criteria
Those who are considered to be ineligible by the principal investigator or investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakamae |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
nakamae@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakamae |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
nakamae@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Institutional Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2020 | Year | 12 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044275
