UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044016
Receipt number R000049982
Scientific Title A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control
Date of disclosure of the study information 2021/04/22
Last modified on 2021/11/04 12:53:56

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Basic information

Public title

A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control

Acronym

A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education

Scientific Title

A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control

Scientific Title:Acronym

A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education

Region

Japan


Condition

Condition

insonmia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test the efficacy of a non-invasive, self-medicating, email-supported, self-help intervention for adults with insomnia symptoms but not receiving medication. A randomized controlled trial will be conducted with (1) a study treatment group (Internet cognitive behavioral therapy with the addition of the "Three Good Things" exercise (TGT)) and (2) a control group (psychological education) as the self-help type intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III


Assessment

Primary outcomes

PSQI; Pittsburgh Sleep Quality Index

Key secondary outcomes

SOL; Sleep Onset Latency
TST; Total Sleep Time
SE; Sleep Efficiency
AIS; Athens Insomnia Scale
GAD-7; Generalized Anxiety Disorder
ISI; Insomnia Severity Index
PHQ-9; Patient Health Questionnaire
CES-D; Center for Epidemiologic Studies Depression Scale
EQ-5D-5L; EuroQOL - 5 dimensions - 5 level


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Internet-based Cognitive Behavioral Therapy program
Three Good Things Exercise

Interventions/Control_2

Sleep Hygiene Education

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Insomnia symptom(PSQI score of 6 and above, AIS score of 6 and above, and ISI score of 8 and above)
Insomnia cause at least 3 nights a week and last for at least 3 months
Subjects with an internet environment
Subjects who can understand Japanese explanation and agree with online consent by voluntary free will

Key exclusion criteria

Moderate or severe anxiety symptom(GAD7 score of 10 and above)
Moderate or severe depressive symptom(GAD7 score of 10 and above)
Alcohol dependence
Drug dependence
Suicidal ideation(PHQ9 Question 2 of 2 and above)
Cerebral organic disease such as Sleep apnea syndrome, restless legs syndrome, epilepsy, dementia, and cerebrovascular disorders
Diagnosis of severe progressive physical disorders such as cancer and heart failure, and under medical treatment
Subjects who are not permitted by primary doctor to participate in this research, for psychological symptoms medication including insomnia
Subjects who do not go to bed twenty to two o'clock(night shift worker)

Target sample size

405


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Shimizu

Organization

Chiba University Graduate School of Medicine
Research Center for Child Mental Development
Cognitive Behavioral Center of Chiba University Hospital

Division name

Department of Cognitive Behavioral Physiology

Zip code

260-8670

Address

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan

TEL

043-226-2027

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Sato

Organization

Chiba University Graduate School of Medicine

Division name

Department of Cognitive Behavioral Physiology

Zip code

260-8670

Address

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan

TEL

043-226-2027

Homepage URL


Email

neurophys1@ml.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba Foundation for Health Promotion & Disease Prevention

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba university hospital clinical research center

Address

1-8-1 Inohana Chuo-ku Chiba 260-8677, Japan

Tel

043-222-7171

Email

chibacrc@mac.com


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

2021 Year 04 Month 22 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

405

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

2020 Year 12 Month 25 Day

Date of IRB

2021 Year 04 Month 19 Day

Anticipated trial start date

2021 Year 06 Month 25 Day

Last follow-up date

2021 Year 10 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 22 Day

Last modified on

2021 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name