UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015211
Receipt number R000016926
Scientific Title A pilot study of E-mail and sleep hygiene education on mental health and sleep.
Date of disclosure of the study information 2014/09/20
Last modified on 2014/09/19 23:18:09

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Basic information

Public title

A pilot study of E-mail and sleep hygiene education on mental health and sleep.

Acronym

A pilot study of E-mail and sleep hygiene education on mental health and sleep.

Scientific Title

A pilot study of E-mail and sleep hygiene education on mental health and sleep.

Scientific Title:Acronym

A pilot study of E-mail and sleep hygiene education on mental health and sleep.

Region

Japan


Condition

Condition

Sleep Problem

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 estimate the effect size of Sleep health program consisted of sleep hygiene and E-mail program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Insomnia Severity Index

Key secondary outcomes

Beck Depression Inventory


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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A program of sleep hygiene lecture and E-mail.

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

15 years-old <=

Age-upper limit

65 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

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuo Ishimura

Organization

Tokyoseitoku University

Division name

Graduate School of Psychology

Zip code


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

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


Email

kenichi.asano1225@gmail.com


Sponsor or person

Institute

Tokyoseitoku University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 09 Month 20 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

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 01 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

2014 Year 09 Month 19 Day

Last modified on

2014 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016926


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name