UMIN-CTR Clinical Trial

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
Email	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
Email	nakamae@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044275