UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049809 |
|---|---|
| Receipt number | R000056730 |
| Scientific Title | Sleep Group Work Study |
| Date of disclosure of the study information | 2022/12/17 |
| Last modified on | 2022/12/16 16:11:45 |
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Basic information
Public title
The study of effectiveness of the group psychotherapy for the patients with sleep related problems
Acronym
The study of effectiveness of the Sleep Group Work
Scientific Title
Sleep Group Work Study
Scientific Title:Acronym
Sleep Group Work Study
Region
| Japan |
Condition
Condition
patients of mental disease with sleep related problem
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the feasibiliy and effectiveness of the group psychotherapy for the sleep related problems.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The lowering of score of Dysfunctional Beliefs and Attitudes about Sleep.
Key secondary outcomes
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
| Other |
Interventions/Control_1
group psychotherapy
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The capability of atttending group psychotherapy
Key exclusion criteria
The incapability of atttending group psychotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Tadokoro |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
0608556
Address
S-1, W-17, Chuo-ku, Sapporo, Japan
TEL
0116112111
tadokoroshigenori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Tadokoro |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
0608556
Address
S-1, W-17, Chuo-ku, Sapporo, Japan
TEL
0116112111
Homepage URL
tadokoroshigenori@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
S-1, W-17, Chuo-ku, Sapporo, Japan
Tel
0116112111
tadokoroshigenori@sapmed.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056730
