UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041947 |
|---|---|
| Receipt number | R000047875 |
| Scientific Title | Efficacy of free association task for sleep-onset insomnia |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2021/03/31 09:17:34 |
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Basic information
Public title
Efficacy of free association task for sleep-onset insomnia
Acronym
Efficacy of free association task for sleep-onset insomnia
Scientific Title
Efficacy of free association task for sleep-onset insomnia
Scientific Title:Acronym
Efficacy of free association task for sleep-onset insomnia
Region
| Japan |
Condition
Condition
Sleep-onset insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the efficacy of free association task for sleep-onset insomnia. The subjects are university students. The duration is 3 weeks, and participants are required to visit the laboratory four times.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
One week and two weeks after the start of the free association task
Key secondary outcomes
Sleep diary (Bed time, Rise time, Sleep latency)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Free association task (Psychological intervention: Participants observe their worry)
Do it twice daily for 2 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese university students
-Sleep onset latency is over 30 minutes 2 days or more per week
-Those who can understand and consent the scope and contents in the trial
Key exclusion criteria
-Those who have been diagnosed with physical and mental illness or sleep disorders
-Those who go to psychiatry or psychosomatic medicine
-Those receiving psychological counseling
-Those taking sleeping pills
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Hara |
Organization
Waseda University
Division name
Advanced Research Center for Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL
080-3026-8126
hara@akane.waseda.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Hara |
Organization
Waseda University
Division name
Advanced Research Center for Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL
080-3026-8126
Homepage URL
hara@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda 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
Waseda University Ethics Review Committee on Research with Human Subjects
Address
2F No.9 building 1-104 Totsukacho Shinjuku Tokyo 169-8050 Japan
Tel
03-5272-1639
rinri@list.waseda.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
| 2020 | Year | 09 | Month | 30 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047875
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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