UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061374 |
|---|---|
| Receipt number | R000070078 |
| Scientific Title | Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits |
| Date of disclosure of the study information | 2026/04/25 |
| Last modified on | 2026/04/27 01:08:03 |
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Basic information
Public title
Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits
Acronym
Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits
Scientific Title
Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits
Scientific Title:Acronym
Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits
Region
| Japan |
Condition
Condition
Attention-deficit/hyperactivity traits in adults
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the feasibility and acceptability of a CBT-based self-help psychoeducational smartphone application for working adults with attention-deficit/hyperactivity traits, and to evaluate changes in attention-deficit/hyperactivity symptoms before and after app use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adult ADHD Self-Report Scale(ASRS)
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
Participants will use a CBT-based self-help psychoeducational smartphone application for 4 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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female adults aged 18 to 39 years.
2.Individuals working at least 20 hours per week.
3.Individuals with attention-deficit/hyperactivity traits who experience difficulties in daily life (ASRS Part A score of 4 items or more).
4.Individuals with access to the internet (via a computer, smartphone, or tablet).
5.Native Japanese speakers who can understand explanations in Japanese and provide informed consent online voluntarily.
Key exclusion criteria
1.Individuals diagnosed with schizophrenia, delusional disorder or other psychotic disorders, dementia, intellectual disability, severe depression (PHQ-9 > 19), bipolar disorder, or substance use disorder.
2.Individuals with a high risk of suicide (PHQ-9 item 9 > 1).
3.Individuals currently receiving structured psychotherapy or planning to receive it during the study period.
4.Individuals who have received cognitive behavioral therapy within the past 6 months.
5.Individuals deemed inappropriate for participation by the investigators.
Target sample size
30
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-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2027
etoaiko@chiba-u.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Eto |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2027
Homepage URL
etoaiko@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
neurophys1@ML.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
| 2026 | Year | 04 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 04 | Month | 25 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070078
