UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047124 |
|---|---|
| Receipt number | R000053754 |
| Scientific Title | Optimizing smartphone CBT to maintain and promote mental well-being in the general population: Resilience Enhancement with Smartphone in LIving ENvironmenTs |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/03/09 10:59:12 |
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Basic information
Public title
Optimizing smartphone CBT to maintain and promote mental well-being in the general population: Resilience Enhancement with Smartphone in LIving ENvironmenTs
Acronym
RESiLIENT Trial
Scientific Title
Optimizing smartphone CBT to maintain and promote mental well-being in the general population: Resilience Enhancement with Smartphone in LIving ENvironmenTs
Scientific Title:Acronym
RESiLIENT Trial
Region
| Japan |
Condition
Condition
Healthy adults in the community
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
RESiLIENT trial is a platform trial involving four 2*2 factorial trials examining efficacy of five smartphone CBT skills. Analysis 1 will focus on the acute intervention effects at week 6 among participants with PHQ-9 scores of 5 or more at week 0. Analysis 2 will focus on the long-term prophylactic effects at week 50 among all participants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in PHQ-9 from baseline to week 6 [Analysis 1]
Key secondary outcomes
1. Incidence of a major depressive episode by week 50 [Analysis 2]
2. Changes in PHQ-9 from baseline to weeks 2, 3, 4, 5; 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50
3. Changes in GAD-7 from baseline to weeks 3, 6, 26, 50
4. Changes in ISI from baseline to weeks 3, 6, 26, 50
5. Changes in WEMWBS from baseline to weeks 3, 6, 26, 50
6. Changes in CBT skills from baseline to weeks 6, 26, 50
7. Changes in WSAS, UWES, HPQ and ED-5D-5L from baseline to weeks 6, 50
8. CSQ-3, adherence to smartphone CBT, co-interventions, safety information at weeks 6 and 50
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Smartphone app for behavioral activation (6 weeks)
Interventions/Control_2
Smartphone app for cognitive restructuring (6 weeks)
Interventions/Control_3
Smartphone app for problem solving (6 weeks)
Interventions/Control_4
Smartphone app for assertion training (6 weeks)
Interventions/Control_5
Smartphone app for behavior therapy for insomnia (6 weeks)
Interventions/Control_6
Smartphone app for behavioral activation + cognitive restructuring (6 weeks)
Interventions/Control_7
Smartphone app for behavioral activation + problem solving (6 weeks)
Interventions/Control_8
Smartphone app for behavioral activation + assertion training (6 weeks)
Interventions/Control_9
Smartphone app for behavioral activation + behavior therapy for insomnia
Interventions/Control_10
Smartphone app for self-checks, Smartphone app for health information, or Waiting list (all 6 weeks)
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People of any sex, aged 18 years or older at the time of providing informed consent
2. In possession of their own smartphone (either iOS or Android)
3. Written informed consent for participation in the trial
4. Completion of all the baseline questionnaires within one week after providing informed consent
Key exclusion criteria
1. Cannot read or write Japanese
2. Receiving mental health treatment at the time of screening
3. Screening PHQ-9 total scores (i) of 15 or higher, or (ii) between 10 and 14, inclusive, and scoring 2 or 3 on its item 9
Target sample size
5200
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Furukawa |
Organization
Kyoto University Graduate School of Medicine/School of Public Health
Division name
Dept of Health Promotion and Human Behavior
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
furukawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Aran |
| Middle name | |
| Last name | Tajika |
Organization
Kyoto University Graduate School of Medicine/School of Public Health
Division name
Dept of Health Promotion and Human Behavior
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
Homepage URL
furukawa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine / School of Public Health
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501 JAPAN
Tel
81757534680
ethcom@kuhp.kyoto-u.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
京都大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1136/bmjopen-2022-067850
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
5364
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053754
