UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Writing therapy on the mental health of college students.
Title of the study (Brief title)	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	Sadamu Nakai
Organization	Tokyo University of Science
Division name	Faculty of Industrial Science and Technology
Address	102 Tomino, Oshamanbe-cho, Yamakoshi-gun, Hokkaido, JAPAN
TEL	01377-2-5111
Email	nakai@rs.kagu.tus.ac.jp

Public contact
Name of contact person	Sadamu Nakai
Organization	Tokyo University of Science
Division name	Faculty of Industrial Science and Technology
Address	102 Tomino, Oshamanbe-cho, Yamakoshi-gun, Hokkaido, JAPAN
TEL	01377-2-5111
Homepage URL
Email	nakai@rs.kagu.tus.ac.jp

Sponsor
Institute	Tokyo University of Science
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029216