UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034927 |
|---|---|
| Receipt number | R000039814 |
| Scientific Title | Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2022/02/10 13:52:00 |
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Basic information
Public title
Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Acronym
Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Scientific Title
Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Scientific Title:Acronym
Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of self-help ICBT without email support for non-clinical adult with insomnia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PSQI(Pittsburgh Sleep Quality Index)
Key secondary outcomes
AIS(Athens Insomnia Scale)
GAD-7(Generalized Anxiety Disorder)
PHQ-9(Patient Health Questionnaire)
CES-D(Center for Epidemiologic Studies Depression Scale)
GTS(General Trust Scale)
CCI(consumer confidence index)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Internet-based Cognitive Behavioral Therapy program
Interventions/Control_2
Three Good Things
Interventions/Control_3
Waiting
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)
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
312
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
Department of Cognitive Behavioral Physiology, Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Sutoh |
| Middle name | |
| Last name | Chihiro |
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
neurophys1@ml.chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine,
Department of Cognitive Behavioral Physiology Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Reseach Institute of Economy, Trade and Industry (RIETI)
Organization
Division
Category of Funding Organization
Other
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
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認知行動生理学，子どものこころの発達教育研究センター，医学部附属病院認知行動療法センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
312
Results
Four weeks of unguided ICBT and TGT exercise for adults with insomnia, both administered as self-help internet interventions without email support, improved insomnia symptoms compared with the WLC group.
Results date posted
| 2022 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 10 | Day |
Baseline Characteristics
The subjects were 112, 41.5% female (32, 40.5% in the ICBT group, 39, 44.3% in the TGT group, and 41, 39.8% in the WCT group), and the mean age was 50.4 years (49.8 years in the ICBT group, 50.5 years in the TGT group, and 51.0 years in the WLC group).
Participant flow
Three hundred twelve people were randomly assigned (106 in the ICBT group, 103 in the TGT group, and 103 in the WLC group), and 270 people (79 in the ICBT group, 88 in the TGT group, and 103 in the WLC group) completed the intervention program and post-intervention survey.
Adverse events
None.
Outcome measures
The adjusted mean changes of PSQI in the ICBT and TGT groups at four weeks from baseline showed a significant improvement compared with the WLC group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039814
