UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016762 |
|---|---|
| Receipt number | R000017234 |
| Scientific Title | A pilot study of E-mail delivered preventive program on sleep and mental health in community. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/03/12 15:56:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study of E-mail delivered preventive program on sleep and mental health in community.
Acronym
A pilot study of E-mail delivered preventive program on sleep and mental health in community.
Scientific Title
A pilot study of E-mail delivered preventive program on sleep and mental health in community.
Scientific Title:Acronym
A pilot study of E-mail delivered preventive program on sleep and mental health in community.
Region
| Japan |
Condition
Condition
sleep problem
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of E-mail delivered preventive program on sleep problem and mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insomnia Severity Index
Key secondary outcomes
BDI
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep hygiene education and E-mail delivered self-help cognitive behavioral therapy.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult with subjective sleep problem.
Key exclusion criteria
Individuals with who have histories of substance abuse, active suicidality, severe mental and physical condition and organic sleep disorders(restless legs syndrome and sleep apnea, etc.).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Ishimura |
Organization
Tokyo Seitoku University
Division name
Graduate School of Psychology
Zip code
Address
23-2, Oji 3chome, Kita-ku, Tokyo, 114-0002 Japan
TEL
03-3927-4116
i-ishimura@tsu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Asano |
Organization
Graduate School of Medicine, Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba city
TEL
043-226-2975
Homepage URL
kenichi.asano@chiba-u.jp
Sponsor or person
Institute
Tokyo Seitoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2015 | Year | 04 | Month | 01 | 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
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017234
