UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055381 |
|---|---|
| Receipt number | R000062938 |
| Scientific Title | A single-arm trial of the effectiveness of remote family psychoeducation for youth caregivers with depressed family |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2026/02/05 10:25:20 |
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Basic information
Public title
A single-arm trial of the effectiveness of remote family psychoeducation for youth caregivers with depressed family
Acronym
A single-arm trial of the effectiveness of remote family psychoeducation for youth caregivers with depressed family
Scientific Title
A single-arm trial of the effectiveness of remote family psychoeducation for youth caregivers with depressed family
Scientific Title:Acronym
A single-arm trial of the effectiveness of remote family psychoeducation for youth caregivers with depressed family
Region
| Japan |
Condition
Condition
Youth caregivers with depressed family
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of remote family psychoeducation for youth caregivers with depressed family
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Hospital Anxiety and Depression Scale
Pre vCBTp
Post vCBTp
Key secondary outcomes
The Kessler Psychological Distress Scale(K6)
The Japanese version of the Zarit Burden Interview(J-ZBI_8)
General Self-Efficacy Scale(GESE)
EuroQol 5 Dimension(EQ-5D-5L)
Client Satisfaction Questionnaire(CSQ-8)
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
| Other |
Interventions/Control_1
Remote family psychoeducation(4Week)
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) A person between the ages of 18 and 39 years old
(2) Persons with a family member within the third degree of kinship who has a diagnosis of depression based on DSM-5 diagnostic criteria
(3) Anyone caring for a family member with depression
(4) Persons who have the ability and environment to use the Internet and computer to receive distance family psychoeducation using a videoconferencing system
Key exclusion criteria
(1) The research subject himself/herself is undergoing treatment for a mental illness
(2) A person who has a serious progressive physical illness and is expected to discontinue the study; or
(3) Those who are judged by the investigator to be unable to continue the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Nakamura |
Organization
The Jikei University School
Division name
Department of Psychiatric Nursing
Zip code
182-8570
Address
8-3-1 kokuryo, Cyofu-City, Tokyo 182-8570, Japan
TEL
81-3-3480-1151
hnakamura@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Nakamura |
Organization
The Jikei University School
Division name
Department of Psychiatric Nursing
Zip code
182-8570
Address
8-3-1 kokuryo, Cyofu-City, Tokyo 182-8570
TEL
81-3-3480-1151
Homepage URL
hnakamura@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School
Institute
Department
Personal name
Hideki Nakamura
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine, research ethics committee
Address
3-19-18, Nishishimbashi,Minato-ku,Tokyo
Tel
03-3433-1111
rinri@jikei.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 | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062938
