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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name