UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047913 |
|---|---|
| Receipt number | R000054411 |
| Scientific Title | Cross-sectional survey on the relationship between ADHD symptoms and stress-related factors in the adult |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/11/29 15:33:18 |
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Basic information
Public title
Survey on the relationship between ADHD symptoms and stress-related factors
Acronym
Relationship between ADHD symptoms and stress-related factors
Scientific Title
Cross-sectional survey on the relationship between ADHD symptoms and stress-related factors in the adult
Scientific Title:Acronym
The relationship between ADHD symptoms and stress-related factors in the adult.
Region
| Japan |
Condition
Condition
adult attention deficit hyperactivity disorder(adult ADHD)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to investigate stressors in the adult population with ADHD symptoms. The secondary purpose is to examine the relationship between stressors in adults with ADHD symptoms and various psychological and physical conditions .
Basic objectives2
Others
Basic objectives -Others
We will examine the association between ADHD symptoms and stressors, stress coping, stress responses, depressive symptoms, and anxiety / fear of COVID-19 infection.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in Interpersonal Stress Event Scale scores between groups with ADHD symptoms and groups without ADHD symptoms
Key secondary outcomes
Differences in scores of Brief COPE, PHRF-SCL [SF], PHQ-9, FCV-19S-J between the group with ADHD symptoms and the group without ADHD symptoms
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who understand the purpose of the research and have consent to participate in the research online.
(2) Those who are 18 years of age or older at the time of participation in the research.
Key exclusion criteria
Nothing special
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities,
Zip code
6628501
Address
1-155 Uegahara Ichibancho, Nishinomiya-shi, Hyogo, JAPAN
TEL
0798544517
hisaono@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities,
Zip code
6628501
Address
1-155 Uegahara Ichibancho, Nishinomiya-shi, Hyogo, JAPAN
TEL
0798544517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Department of Integrated Psychological Sciences, School of Humanities, Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Department of Integrated Psychological Sciences, School of Humanities, Kwansei Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University Committee for Regulations for Behavioral Research with Human Participants
Address
1-155 Uegahara Ichibancho, Nishinomiya-shi, Hyogo, JAPAN
Tel
0798546104
human-ethic@kwansei.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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://kwanseio365-my.sharepoint.com/:b:/g/personal/bbj00305_nuc_kwansei_ac_jp/EZbWTxVbSONAqTMk2PdH
Publication of results
Partially published
Result
URL related to results and publications
japanese journal of clinical psychiatry 52 999-1005 2023
Number of participants that the trial has enrolled
501
Results
The adult ADHD group had significantly higher PHQ-9 scores, indicating increased depression, compared to non-ADHD group. The adult ADHD group also scored significantly higher in interpersonal conflict scores, inferiority scores, and burnout scores on the Interpersonal Stress Events Scale, reflecting elevated interpersonal stress. Mediation analysis implied ADHD symptoms might heighten stress related to interpersonal inferiority, potentially worsening depression.
Results date posted
| 2023 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A cross-sectional survey targeting adults aged 18 and above was conducted. Participants were recruited through a crowdsourcing service (Lancers), and a total of 502 individuals (256 males, 244 females, 2 non-respondents, mean age:42.33 years old) were included in the analysis.
Participant flow
Consent for participation in the research was obtained through online documents, after explaining the purpose of the study. The online survey was conducted using the online survey service (Qualtrics).
Adverse events
No adverse events.
Outcome measures
The primary objective was to investigate the impact of the presence or absence of ADHD symptoms on PHQ-9 scores, mediated through interpersonal conflict scores, interpersonal inferiority scores, and interpersonal burnout scores on the Interpersonal Stress Events Scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Cross-sectional research.
Management information
Registered date
| 2022 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054411
