UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025370 |
|---|---|
| Receipt number | R000029216 |
| Scientific Title | Effects of Writing therapy on the mental health of college students. |
| Date of disclosure of the study information | 2016/12/26 |
| Last modified on | 2018/05/23 14:04:51 |
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Basic information
Public title
Effects of Writing therapy on the mental health of college students.
Acronym
Effects of Writing therapy on the mental health of college students.
Scientific Title
Effects of Writing therapy on the mental health of college students.
Scientific Title:Acronym
Effects of Writing therapy on the mental health of college students.
Region
| Japan |
Condition
Condition
College students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of effective stress reduction method.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States(POMS).
State-Trait Anxiety Inventory.
Salivary amylase activity.
Salivary Chromogranin A concentration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The treatment group is asked to write about the classes and human relations (12min x 5 days).
Interventions/Control_2
Control group is asked to write about plans for the upcoming 24 hr (12min x 5 days).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non smoker
Key exclusion criteria
Individuals who have history of oschizophrenia, or other psychiatric disorder.
Smoker
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadamu Nakai |
Organization
Tokyo University of Science
Division name
Faculty of Industrial Science and Technology
Zip code
Address
102 Tomino, Oshamanbe-cho, Yamakoshi-gun, Hokkaido, JAPAN
TEL
01377-2-5111
nakai@rs.kagu.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadamu Nakai |
Organization
Tokyo University of Science
Division name
Faculty of Industrial Science and Technology
Zip code
Address
102 Tomino, Oshamanbe-cho, Yamakoshi-gun, Hokkaido, JAPAN
TEL
01377-2-5111
Homepage URL
nakai@rs.kagu.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Scienc
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
| 2016 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 26 | 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
| 2016 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029216
