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 |
* 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
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
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
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
