UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Web-based cognitive behavioral therapy program for patients with obsessive-compulsive disorder: A rescue trial
Acronym	A rescue trial of web based-cognitive behavioral therapy for obsessive-compulsive disorder
Scientific Title	Internet-based cognitive behavioral therapy for patients with obsessive-compulsive disorder: A rescue trial
Scientific Title:Acronym	A rescue trial of Internet-based cognitive behavioral therapy for obsessive-compulsive disorder
Region	Japan

Condition
Condition	Obsessive-compulsive disorder
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to treat patients with obsessive-compulsive disorder assigned to the waiting group in the preceding randomized controlled trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Assessments of severity by using Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) will be performed at baseline and at the end of the intervention (12 weeks after the beginning of the intervention).
Key secondary outcomes	Obsessive-Compulsive Inventory, Working Alliance Inventory-Short From, EuroQol 5 Divison, Patient Health Questionnaire-9, Generalized Anxiety Disorder -7 at baseline and at the end of the intervention (12 weeks after the beginning of the intervention).

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	Behavior,custom
Interventions/Control_1	Self-help based on cognitive behavioral science. Patients are going to conduct self-help by using e-learning with minimal guidance by a cognitive behavioral therapist, at once a week for 12 consecutive weeks. The treatment module includes psychoeducation, case conceptualization, behavioral experiment, cognitive reconstruction, creation of anxiety hierarchy vote, exposure response obstruction method, and recurrence prevention.
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	15 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Inclusion criteria: 1) Patients meets the diagnostic criteria for obsessive-compulsive disorder by the Mini-International Neuropsychiatric Interview (M.I.N.I.) meets with a total Y-BOCS score of 14 or more; 2) Those who have completed the 12-week waiting period in the previous randamized controlled trial (Study No. G2019017); 3) The age at the time of obtaining consent is between 15 and 60; 4) A person who intends to participate voluntarily and agrees to the research content after explaining the research content; 5) Ordinary treatment is given, and no new initiation or additional modification of drug therapy is planned during the study period; 6) Personal computer, tablet, smartphone, or other computer device capable of communication, or the guardian of a subject who is less than an adult owns the above device, and the subject himself or herself substantially uses it on a daily basis; 7) Have an Internet communication environment and have skills (send mail, open files, receive mail and read); 8) Has not received any cognitive-behavioral therapy, including exposure-response interference, for the last 2 years.
Key exclusion criteria	Exclusion criteria: 1) Organic disorders of the brain (including dementia), psychotic disorders, bipolar disorders, serious psychiatric disorders such as drug dependence, etc. are complicated, and cognitive-behavioral therapy is expected to be interrupted due to deterioration of these symptoms; 2) The cognitive-behavioral therapy is expected to be interrupted due to the imminent risk of suicide; 3) Cognitive behavioral therapy is expected to be interrupted due to repeated antisocial behavior; 4) Cognitive-behavioral therapy is expected to be discontinued due to severe progressive physical illness; 5) Due to severe stress reaction and dissociation symptoms due to acute stress disorder and post-traumatic stress disorder, it is difficult to expose to feared subjects; 6) There are significant problems due to attention deficit and hyperactivity disorderand autism spectrum disorder, and it is predicted that it will be difficult to receive stable treatment in the study conducted in this clinical study; 7) Those who reject the ERP; 8) Any other person who is judged by the investigator or the therapist to be unsuitable for the safe conduct of this study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Shimizu
Organization	Graduate School of Medicine at Chiba University
Division name	Department of Cognitive Behavioral Physiology
Zip code	2608670
Address	1-8-1, Inohana, Chuo-ku Chiba, 2608670 Japan
TEL	043-226-2027
Email	neurophys1@ML.chiba-u.jp

Public contact
Name of contact person	1st name Kazuki Middle name Last name Matsumoto
Organization	Chiba University
Division name	Research Center for Child Mental Development
Zip code	2608679
Address	1-8-1, Inohana, Chuo-ku Chiba, 2608670 Japan
TEL	043-226-2975
Homepage URL
Email	axpa0219@chiba-u.jp

Sponsor
Institute	Research Center for Child Metnal Development, Chiba University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
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	Chiba University Hospital
Address	1-8-1, Inohana, Chuo-ku Chiba, 2608670 Japan
Tel	043-222-7171
Email	ayamazaki@ office.chiba-u.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	千葉大学医学部附属病院（千葉県）、福井大学医学部附属病院（福井県）

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 10 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	12
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	2020 Year 02 Month 22 Day
Date of IRB	2020 Year 04 Month 01 Day
Anticipated trial start date	2020 Year 06 Month 17 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 09 Day
Last modified on	2021 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046450