UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051280 |
|---|---|
| Receipt number | R000057995 |
| Scientific Title | Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic Six arms randomized controlled trial |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2024/12/05 17:06:58 |
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Basic information
Public title
Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic
Six arms randomized controlled trial
Acronym
Validation of mental training apps for subthreshold symptoms
Scientific Title
Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic
Six arms randomized controlled trial
Scientific Title:Acronym
subthreshold- MENTORE App.
Region
| Japan |
Condition
Condition
subthreshold insomnia, subthreshold depression, subthreshold panic
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore effectivity of mental training web app for subthreshold insomnia, subthreshold depression and subthreshold panic on six arms randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subthreshold insomnia: amount of change PSQI(Pittsburgh Sleep Quality Index) from 0 week to 4 weeks.
subthreshold depression: amount of change CES-D(Center for Epidemiologic Studies Depression Scale ) from 0 week to 4 weeks.
subthreshold insomnia: amount of change PAS(Panic and Agoraphobia Scale)from 0 week to 4 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention 1/ subthreshold insomnia: to do insomnia program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Interventions/Control_2
Control 2/ Siamese app once a day log in, 4weeks
Interventions/Control_3
subthreshold depression: to do anxiety and depression program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Interventions/Control_4
Control 4/ Siamese app once a day log in, 4weeks
Interventions/Control_5
subthreshold insomnia: to do panic program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Interventions/Control_6
Control 6/ Siamese app once a day log in, 4weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 18 to 70 years old
2 People who do not go to the hospital due to mental or physical illness
3 no suicidal ideation
4 have an internet environment
5 Japanese speaker and persons can be online consent
6 Apply to below A to C
A subthreshold insomnia
PSQi6 or more and Insomnia symptoms less than 3 month
B subthreshold depression
Does not meet PHQ9 diagnostic criteria for depression and CESD 16 or more
and depression symptoms less than 2 years
C subthreshold panic
PAS 9 or more and panic symptoms less than 1 month
note that
If subthreshold panic overlaps, it is classified as a panic group, and if subthreshold insomnia and subthreshold depression overlap, it is classified as a depression group
Key exclusion criteria
1 People who have been diagnosed with mental illness including sleep disorder, depression, panic disorder
2 PHQ9 section 2 score 2 or more
3 diagnosed with a serious progressive physical disease such as cancer or heart failure and are currently visiting a hospital
4 undergoing drug therapy for mental or physical symptoms however, use of OTC drugs and supplements purchased at pharmacies is not excluded
5 suspected of having sleep apnea syndrome or restless legs syndrome
6 Night shift workers
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
2608670
Address
1-8-1 inohana chuo-ku chiba city Chiba
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Research Center for Child Mental Developmen
Zip code
2608670
Address
1-8-1 inohana chuo-ku chiba city Chiba
TEL
043-226-2027
Homepage URL
k.taguchi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiba University Hospital
Address
1-8-1 inohana chuo-ku chiba city Chiba
Tel
043-222-7171
prc-jim@chiba-u.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
| 2023 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
nothing
Publication of results
Unpublished
Result
URL related to results and publications
under article submission
Number of participants that the trial has enrolled
886
Results
The results of the four-week Mentor Program intervention suggested that the subthreshold depression and subthreshold insomnia programs improved depressive symptoms and insomnia symptoms in each group, while no significant improvement was observed in subthreshold panic. No serious adverse events occurred in either group, suggesting safety for subthreshold subjects.
Results date posted
| 2024 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were aged 18-70 years and did not visit a hospital owing to any disease. Moreover, they all met the following criteria:
To select individuals with subthreshold depression, Among those who were not excluded as having depression, those with a CES-D score of 16 or higher were eligible. Individuals with subthreshold insomnia who had PSQI scores greater than 6 and insomnia symptoms lasting less than 3 months were eligible. Individuals with subthreshold panic who had a PAS score greater than 9 and who experienced anxiety-related panic symptoms continuously lasting less than 1 month were eligible. In the case of duplicate symptoms, if the panic score met the eligibility criteria, participants were allocated to subthreshold panic preferentially since those symptoms were more specific than the other two. Subthreshold depression sometimes overlaps with subthreshold insomnia; hence, participants were allocated to the subthreshold depression group. The exclusion criteria included persons with a history of diagnosed depression, insomnia, or panic disorder, and persons who experienced difficulty or extreme difficulty in daily life owing to anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7) scale or owing to depressive thoughts on the PHQ-9.
Participant flow
Participants were recruited through an internet survey company. Participants who met the eligibility criteria were assigned to either subthreshold depression, subthreshold insomnia, or threshold panic, and were randomly assigned to an intervention or control group based on the three symptoms (six groups).
The intervention group participated in a four-week mentoring program, while the sham group logged in and recorded the weather, and were assessed before and after the intervention and at a one-month follow-up.
Adverse events
Non applicable.
Outcome measures
Primary Endpoints
Each primary endpoint was the change from the screening (T1) score to the 4-week follow-up (T4) score in each group, as described below:
Center for Epidemiological Studies Depression Scale (CESD) in the subthreshold depression group
The Pittsburgh Sleep Quality Index (PSQI) in the subthreshold insomnia group
Panic and Agoraphobia Scale (PAS) in the subthreshold panic group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057995
