UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048547 |
|---|---|
| Receipt number | R000055305 |
| Scientific Title | Validation study of the effect of the online counseling (electronic-Interpersonal Counseling: e-IPC) for depression in adults with ADHD symptoms |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2023/01/31 15:55:15 |
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Basic information
Public title
Effects of the online interpersonal counseling on depression in adults with ADHD symptoms
Acronym
Effects of the online interpersonal counseling on depression in adults with ADHD symptoms
Scientific Title
Validation study of the effect of the online counseling (electronic-Interpersonal Counseling: e-IPC) for depression in adults with ADHD symptoms
Scientific Title:Acronym
Effects of the online counseling for depression in adults with ADHD symptoms
Region
| Japan |
Condition
Condition
Attention-deficit hyperactivity disorder: ADHD
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to verify the usefulness of e-IPC for depression in adults with ADHD symptoms.
Secondary objectives are to examine the short-term and long-term effects of e-IPC on ADHD symptoms, fear of COVID-19 infection, mental health, stress, and brain activity. Furthermore, we examine the relevance of these factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the difference in the amount of change in SDS total score between before intervention and 4 weeks after intervention in the e-IPC group and the waiting group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
electronic-Interpersonal Counseling: e-IPC
Counseling is held 3 times a week for 50 minutes each time. In the first counseling, we ask about the subject's most recent stress, the history of stress onset, and current coping methods. We decide which areas of interpersonal problem areas to focus on. In the second counseling session, we discuss the problem areas determined in the first counseling session, think about coping strategies, and do role-plays. In addition, we will discuss the feasibility and future potential of the countermeasures. In the third counseling session, we will listen to the progress since the last counseling session, review specific progress in coping with stress, and ascertain the client's current stress.
Interventions/Control_2
Counseling with listening
Counseling using basic listening techniques such as nodding, repetition, summarizing, and clarifying emotions through counseling sessions 1-3.
Interventions/Control_3
Waiting
Waiting without intervention for the same period as other intervention methods(e-IPC, Counseling with listening).
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who understand the purpose of the research and can obtain written consent to participate in the research.
(2) Those who are 18 years old or older at the time of study participation.
(3) Those with ADHD symptoms.
(4) Subjects who are depressed.
(5) Subjects who can obtain permission to participate in this study from their attending physician if they are undergoing treatment for some disease.
Key exclusion criteria
(1) Persons at high risk of suicide
Those who fall under "moderate" and "high" in the M.I.N.I. "suicide risk" item.
Target sample size
60
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
0798-54-4517
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
0798-54-4517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kwansei Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subiects (KGIRB)
Address
1 Gakuen Uegahara, Sanda City, Hyogo Prefecture 669-1330
Tel
0798-54-6104
med-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 | 08 | Month | 02 | 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
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055305
