UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039607 |
|---|---|
| Receipt number | 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 | 2022/10/16 09:47:38 |
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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
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
okuda_tomoko@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045028
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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