UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042193 |
|---|---|
| Receipt number | R000048158 |
| Scientific Title | A pilot trial to examine the effectiveness and feasibility of the mobile application-based cognitive behavioral therapy for depression and anxiety |
| Date of disclosure of the study information | 2020/10/21 |
| Last modified on | 2023/07/19 11:16:35 |
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Basic information
Public title
A pilot trial to examine the effectiveness and feasibility of the mobile application-based cognitive behavioral therapy for depression and anxiety
Acronym
ICBT for depression and anxiety
Scientific Title
A pilot trial to examine the effectiveness and feasibility of the mobile application-based cognitive behavioral therapy for depression and anxiety
Scientific Title:Acronym
ICBT for depression and anxiety
Region
| Japan |
Condition
Condition
depression and anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying the effectiveness and feasibility of the mobile-application based cognitive behavioral therapy for depression and anxiety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
change in sum of PHQ-9 and GAD-7 scores from pre- to post-12 week intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A mobile application-based cognitive behavioral therapy for 12 weeks
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions:
1) Have mild or moderately severe depressive symptoms (PHQ-9 score of 5 to 19 points)
2) Have mild or moderate anxiety symptoms (GAD-7 score of 5 to 14 points)
3) Men and women between the ages of 16 and 65
4) Those who receive medical treatment by a psychiatrist or psychosomatic physician.
5) Those who can visit Chiba University or have an interview with web conferencing software or telephone about once every four weeks
6) Those who can use the online program for about 12 weeks with PC, smartphone, or tablet
7) Those who understand the explanation in Japanese and have obtained the consent of the person (in the case of minors, the person and the guardian)
Key exclusion criteria
Those who meet any of the following conditions are not eligible:
1) Those who have an imminent risk of suicide
2) Persons with serious mental disorders such as organic brain disorders (including dementia), psychotic disorders, bipolar disorders, and drug dependence
3) Those who are not allowed to participate in this study by their principal doctor
4) Those who have difficulty in contacting researchers
5) Those who are receiving psychotropic drug therapy and whose prescription is expected to change during the period of participation in this study
6) Those who are currently receiving the therapy designated as prohibited
7) The principal investigator or the research coordinator judges that it is inappropriate to carry out this study safely.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Graduate school of medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo, Chiba, Chiba
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tamura |
Organization
Chiba University
Division name
Graduate school of medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo, Chiba, Chiba
TEL
043-226-2027
Homepage URL
m.tamura.cmc@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Chiba University Certified Clinical Research Review Board
Address
1-8-1 Inohana, Chuo, Chiba, Chiba
Tel
043-226-2616
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
| 2020 | Year | 10 | Month | 21 | 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
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
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
