UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040699 |
|---|---|
| Receipt number | R000046450 |
| Scientific Title | Internet-based cognitive behavioral therapy for patients with obsessive-compulsive disorder: A rescue trial |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/12/10 16:19:23 |
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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
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
axpa0219@chiba-u.jp
Sponsor or person
Institute
Research Center for Child Metnal Development, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046450
