UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044770 |
|---|---|
| Receipt number | R000051125 |
| Scientific Title | A Randomized Controlled Trial of Internet-Based Psychosocial Intervention for Safety Behaviors on Insomnia Symptoms |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2022/07/06 11:19:01 |
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Basic information
Public title
Psychological Intervention Program on Insomnia Symptoms
Acronym
Psychological Intervention Program on Insomnia Symptoms
Scientific Title
A Randomized Controlled Trial of Internet-Based Psychosocial Intervention for Safety Behaviors on Insomnia Symptoms
Scientific Title:Acronym
Prevention of Safety Behaviors on Insomnia Symptoms (PSBIS)
Region
| Japan |
Condition
Condition
Insomnia Symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of interventions for sleep-related safety behaviors in adults without insomnia disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
ISI (Insomnia Severity Index)
Key secondary outcomes
SOL (Sleep Onset Latency)
WASO (Wake after sleep onset)
NOA (Number of awaking)
TST (Total Sleep Time)
SE (Sleep Efficiency)
PHQ-9 (Patient Health Questionnaire)
GAD-7 (Generalized Anxiety Disorder)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
FSET for sleep (False Safety Aid Elimination Therapy for Sleep Treatment)
Interventions/Control_2
PHET (Physical Health Education Treatment)
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Insomnia symptoms (ISI score of 8 and above).
2) Interest in improving their own sleep and willingness to work on tasks and to record their sleep.
3) Subjects with access to a computer to view online websites.
4) Subjects who can understand Japanese explanation and agree with online consent by voluntary free will.
Key exclusion criteria
1) Presence of treatment and hospital visits for sleep disorders or mental illness.
2) Subjects engaged in shift work, including late night.
3) Suicidal ideation (PHQ9 Question 2 of 2 and above).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Ishikawa |
Organization
Doshisha University
Division name
Faculty of psychology
Zip code
610-0394
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL
0774-65-7092
ishinn@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Ubara |
Organization
Doshisha Unibersity
Division name
Graduate School of Psychology
Zip code
610-0394
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL
0774-65-8276
Homepage URL
cykc1005@mail2.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
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
Doshisha University Faculty of Psychology Research Ethics Committee
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
Tel
0774-65-7897
ji-sinri@mail.doshisha.ac.jp
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 | 07 | Month | 06 | 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
58
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
| 2021 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 08 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051125
