UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053619 |
|---|---|
| Receipt number | R000061061 |
| Scientific Title | Exploratory study of effect on depression and behavior change with smartphone-based behavioral activation |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/08/20 16:36:20 |
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Basic information
Public title
Exploratory study of effect on depression and behavior change with smartphone-based behavioral activation
Acronym
Exploratory study for efficacy of smartphone-based behavioral activation
Scientific Title
Exploratory study of effect on depression and behavior change with smartphone-based behavioral activation
Scientific Title:Acronym
Exploratory study for efficacy of smartphone-based behavioral activation
Region
| Japan |
Condition
Condition
Depressive symptoms
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory investigation the effect of a gamified smartphone-based behavioral activation for presymptomatic disease sample.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Health Questionnaire - 9
Key secondary outcomes
Environmental Reward Observation Scale
Fatigue Severity Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use the "Zoo Repo", an smartphone application of behavioral activation, for 4 weeks.
Interventions/Control_2
Use the "BEARS", an web application of behavioral activation, for 4 weeks.
Interventions/Control_3
Waiting-list
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18 years old or older and under 29 years old.
Person with 5 or greater and 19 or less with depressive symptoms(PHQ-9).
Those who have consent to participate in this research.
Key exclusion criteria
The score of item 9 in PHQ-9 has 3 or grater.
Those who are currently attending a medical institution due to psychological problems.
Those who are currently receiving psychological counseling.
Others who have been determined to be inappropriate as a target by researchers.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sugiyama |
Organization
Kanagawa University
Division name
Faculty of Human Sciences
Zip code
221-8686
Address
3-27-1 Rokkakubashi, Kanagawa-ku, Yokohama-shi, Kanagawa
TEL
07054506914
sugy@xf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Yamasato |
Organization
Yokohama City University
Division name
Research and Industry-Academia Collaboration Division
Zip code
220-0012
Address
3-7-1 Minatomiari, Nishi-ku, Yokohama-shi, Kanagawa
TEL
05035757535
Homepage URL
takeda.ami.nm@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Science and Technology Promotion Organization (JST)
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
Kanagawa University
Address
3-27-1 Rokkakubashi, Kanagawa-ku, Yokohama-shi, Kanagawa
Tel
0454815661
kenkyu-hitorinri@kanagawa-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 15 | 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
67
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
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061061
