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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039607
Receipt No. R000045028
Scientific Title Clinical trial of group cognitive behavioral therapy (CBT) for parents of individuals with hikikomori (randomized controlled trial of the efficacy of the CBT group compared to the waiting group)
Date of disclosure of the study information 2020/02/26
Last modified on 2021/08/28

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Basic information
Public title A study of group cognitive behavioral therapy for parents of individuals with hikikomori
Acronym Cognitive behavioral therapy for parents of hikikomori
Scientific Title Clinical trial of group cognitive behavioral therapy (CBT) for parents of individuals with hikikomori (randomized controlled trial of the efficacy of the CBT group compared to the waiting group)
Scientific Title:Acronym RCT of group CBT for parents of hikikomori
Region
Japan

Condition
Condition none
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether group cognitive behavioral therapy is more effective for parents of individuals with hikikomori than the waiting group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total time of one week from (1) to (3) of Individuals with hikikomori : (1) Talking face-to-face with participants at home,
(2) Talking face-to-face with other family members and others at home, (3) individual with hikikomori goes out,
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Program: Once a week for 60 minutes. And 8 times in total.

Interventions/Control_2 We distribute leaflet about withdrawal.
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

Not applicable
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Parents who meet all of the following conditions (in principle, a mother, but may be a father).
1) to be under 70 years old.
2) to be able to participate in all programs.
3) Age of the child is 16 years or older.
Key exclusion criteria Those who meet any of the following conditions are not eligible.
1) Those who are expected to be suspended in case the participant has a severe mental or physical illness such as brain disorder (including dementia), psychotic disorder, bipolar disorder, drug dependence, etc.
2) In case the individual with hikikomori, who is the child of the participant, cannot obtain the consent of the attending physician who is a psychiatric department.
3) In case a child with hikikomori is committing violence at home.
4) When there are two or more individuals with hikikomori at home.
5) The individual who is judged inappropriate by the investigator or the therapist in charge of the study to perform this test safely.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name EIJI
Middle name
Last name SHIMIZU
Organization Chiba University Hospital
Division name Cognitive Behavioral Therapy Center
Zip code 260-8677
Address 1-8-1 inohana chuo-ku chiba-city CHIBA
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name TOMOKO
Middle name
Last name OKUDA
Organization Chiba University Graduate School of Medicine
Division name Cognitive behavioral physiology
Zip code 260-8677
Address 1-8-1 inohana chuo-ku chiba-city CHIBA
TEL 043-226-2027
Homepage URL
Email okuda_tomoko@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital Clinical Research Center
Address 1-8-1 inohana chuo-ku chiba-city CHIBA
Tel 043-222-7171
Email chibacrc@mac.com

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 02 Month 26 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 20 Day
Date of IRB
2019 Year 11 Month 18 Day
Anticipated trial start date
2020 Year 02 Month 28 Day
Last follow-up date
2022 Year 09 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 02 Month 26 Day
Last modified on
2021 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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