UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021509
Receipt No. 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 (Ver. 15)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023545