UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021509
Receipt number R000023545
Scientific Title Effectiveness study of internet based cognitive behavioral therapy for insomnia: a pilot randomized controlled trial
Date of disclosure of the study information 2016/03/17
Last modified on 2019/09/18 17:59:58

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Basic information

Public title

Effectiveness study of internet based cognitive behavioral therapy for insomnia: a pilot randomized controlled trial

Acronym

Internet based CBT for insomnia: a pilot randomized controlled trial

Scientific Title

Effectiveness study of internet based cognitive behavioral therapy for insomnia: a pilot randomized controlled trial

Scientific Title:Acronym

Internet based CBT for insomnia: a pilot randomized controlled trial

Region

Japan


Condition

Condition

Insomnia Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effectiveness of ICBT for insomnia disorder

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

PSQI(Pittsburgh Sleep Quality Index)

Key secondary outcomes

anxiety score in HADS(Hospital Anxiety and Depression Scale)
CES-D(Center for Epidemiologic Studies Depression Scale)
EQ-5D(EuroQol-5D)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Internet cognitive behavioural therapy

Interventions/Control_2

Usual care

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Primary diagnosis of Insomnia disorder
HADS anxiety score < 10
CES-D < 30
Use of sleep medications
Insomnia symptoms of the following criteria remain even after pharmacotherapy
PSQI > 5.5

Key exclusion criteria

psychotic disorders
active suicidality
organic brain disorders
antisocial behaviours
other severe mental / physical conditions

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shimizu
Middle name
Last name Eiji

Organization

Chiba University Graduate School of Medicine

Division name

Research Center for Child Mental Development, 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

neurophys1@ML.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

daisuke-sato@umin.ac.jp


Sponsor or person

Institute

Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

Tel

043-226-2616

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

千葉大学大学院医学研究院(千葉県)
Chiba University Graduate School of Medicine(Chiba)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 17 Day


Related information

URL releasing protocol

https://bmjopen.bmj.com/content/8/1/e018220.info

Publication of results

Published


Result

URL related to results and publications

https://www.jmir.org/2019/4/e12686/

Number of participants that the trial has enrolled

23

Results

These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy.

Results date posted

2019 Year 09 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 04 Month 11 Day

Baseline Characteristics

patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines

Participant flow

A total of 32 patients applied to participate. A final total of 23 patients attended the baseline assessment, and randomly assigned to the ICBT plus UC and UC groups.

Adverse events

There were no reports of adverse events in either group during the study.

Outcome measures

The adjusted mean reduction in PSQI at week 6 from baseline in the ICBT plus UC group was significantly larger than the adjusted mean reduction in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone.

Plan to share IPD

not planned

IPD sharing Plan description

N/A


Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 01 Month 18 Day

Date of IRB

2016 Year 01 Month 20 Day

Anticipated trial start date

2016 Year 03 Month 27 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 05 Month 10 Day

Date trial data considered complete

2018 Year 05 Month 31 Day

Date analysis concluded

2018 Year 07 Month 10 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 17 Day

Last modified on

2019 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name