UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052027 |
|---|---|
| Receipt number | R000059386 |
| Scientific Title | Effects of an online AIRIKI program about romantic relationships and marriage for persons with mental disorders: a randomized controlled trial |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2023/11/09 16:13:40 |
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Basic information
Public title
Effects of an online AIRIKI program about romantic relationships and marriage for persons with mental disorders
Acronym
AIRIKI RCT
Scientific Title
Effects of an online AIRIKI program about romantic relationships and marriage for persons with mental disorders: a randomized controlled trial
Scientific Title:Acronym
AIRIKI online program RCT
Region
| Japan |
Condition
Condition
psychiatric disorders; Schizophrenia, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, panic disorder, dissociative obstacle, eating disorder, developmental disability
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clear how the online AIRIKI program effects on self-esteem or hope of people with mental disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Self-esteem scale scores
Key secondary outcomes
Hope scale scores
Confidence on communication scale scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: participating in online group-work program about romantic relationships and marriage with 4-6 participants and 3 facilitators for 2 days. The group-work last 150 minutes on each day.
Interventions/Control_2
Control: receive program after they finish assessment
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.Adults who are 18 years of age or order and diagnosed with a mental disorder and currently undergoing psychiatric outpatient treatment
2.Participant's psychiatrist determinates that the patient can decide their study participation following their own will.
3.They are able to participate in group discussion activities without difficulty using Japanese.
4.They have never participated in AIRIKI program
5.They can use and prepare their own personal computer, smartphone, or tablet-type device to access ZOOM. Additionally, they do not mind showing their face in ZOOM activities.
6. They are not married
Key exclusion criteria
They do not meet exclusion criteria
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Kusaka |
Organization
Shonan University of Medical Sciences
Division name
Division of Nursing
Zip code
244-0806
Address
16-48, kamishinano, totsuka-ku. Yokohama-city, Kanagawa-ken, 244-0806, JAPAN
TEL
045-821-0111
momoko.kusaka@sums.ac.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Kusaka |
Organization
Shonan University of Medical Sciences
Division name
Division of Nursing
Zip code
244-0806
Address
16-48, kamishinano, totsuka-ku. Yokohama-city, Kanagawa-ken, 244-0806, JAPAN
TEL
045-821-0111
Homepage URL
momoko.kusaka@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Momoko Kusaka
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan University of Medical Sciences
Address
16-48, kamishinano, totsuka-ku. Yokohama-city, Kanagawa-ken, 244-0806, JAPAN
Tel
045-821-0111
momoko.kusaka@sums.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
| 2023 | Year | 08 | Month | 28 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059386
