UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of the effect of sleep health program in community.
Title of the study (Brief title)	A randomized controlled trial of the effect of sleep health program in community.
Region	Japan

Condition
Condition	Subjective difficulties of sleep
Classification by specialty	Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose in this study is to evaluate the effectiveness of sleep health program consisted of sleep hygiene and E-mail program by using randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Insomnia Severity Index
Key secondary outcomes	Beck Depression Inventory Dysfunctional. Beliefs and Attitudes about Sleep scale Sleep efficiency (Sleep diary)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Lecture of sleep hygiene E-mail delivered brief behavioral therapy for insomnia (4 weeks)
Interventions/Control_2	Lecture of sleep hygiene E-mail delivered breathing training(4 weeks)
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	15 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	People 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	124

Research contact person
Name of lead principal investigator	Ikuo Ishimura
Organization	Tokyoseitoku University
Division name	Graduate School of Psychology
Address	23-2, Oji 3chome, Kita-ku, Tokyo, 114-0002 Japan
TEL	03-3927-4116
Email	i-ishimura@tsu.ac.jp

Public contact
Name of contact person	Kenichi Asano
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1, inohana, Chuo-ku, Chiba city
TEL	043-226-2975
Homepage URL
Email	kenichi.asano1225@gmail.com

Sponsor
Institute	Tokyoseitoku University
Institute
Department

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)

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 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 22 Day
Anticipated trial start date	2015 Year 02 Month 10 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 10 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019162