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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048547
Receipt No. 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 2022/08/02

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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.
(2) Those who tested positive for M.I.N.I.
Any item other than M.I.N.I.'s "suicide risk" item will be considered "positive" at the time it corresponds to any of the present, past, or lifetime. However, even if they test positive, they can participate in the study if their doctor approves them.
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
Email 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
Email hisaono@kwansei.ac.jp

Sponsor
Institute Kwansei Gakuin University
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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