UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059631 |
|---|---|
| Receipt number | R000068067 |
| Scientific Title | Study on Psychoeducational Interventions for Personal Recovery |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/04 10:08:16 |
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Basic information
Public title
Study on Psychoeducational Interventions for Personal Recovery
Acronym
Study on Psychoeducational Interventions for Personal Recovery
Scientific Title
Study on Psychoeducational Interventions for Personal Recovery
Scientific Title:Acronym
Study on Psychoeducational Interventions for Personal Recovery
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study demonstrates that a brief psychoeducational intervention focused on personal recovery, administered to psychiatric patients attending outpatient mental health clinics, can promote understanding of the personal recovery concept and potentially facilitate personal recovery itself.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery Attitudes Questionnaire
Key secondary outcomes
RAS,SISR part A,ISMI-10,
Open ended question
Please freely write about your life goals or things you want to do.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention used in the study is a presentation of a video centered on explaining the concept of personal recovery on an online platform.
Interventions/Control_2
The control group will not be shown the video until the study participation is complete.
(For ethical reasons, video viewing opportunities will be provided upon completion of research participation.)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Schizophrenia patients attending outpatient psychiatric clinics
(2) Any disease stage
(3) Age 18 years or older, 65 years or younger (at registration)
(4) Gender is not a factor.
(5) Individuals who have provided electronic consent for research participation.
Key exclusion criteria
(1) Individuals with substance-induced disorders, organic mental disorders, or intellectual disabilities. Individuals who have previously received special programs separate from regular medical treatment regarding personal recovery.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University
Division name
Department of Psychiatry,Graduate School of Medicine
Zip code
980-8574
Address
1-1,Seiryomachi,Aobaku,Sendai city,Miyagi prefecture
TEL
022-717-7262
psy@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakuma |
Organization
Tohoku University
Division name
Department of Psychiatry,Graduate School of Medicine
Zip code
980-8574
Address
1-1,Seiryomachi,Aobaku,Sendai city,Miyagi prefecture
TEL
022-717-7262
Homepage URL
psy@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Atsushi Sakuma
Funding Source
Organization
Tohoku 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
Tohoku University,Department of Psychiatry,Graduate School of Medicine
Address
1-1,Seiryomachi,Aobaku,Sendai city,Miyagi prefecture
Tel
022-717-7262
psy@med.tohoku.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
| 2025 | Year | 11 | Month | 04 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068067
