UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055266 |
|---|---|
| Receipt number | R000063102 |
| Scientific Title | Feasibility Study to Test the Effectiveness of Open Dialogue Training for Psychiatric Staff - single group pre- and post-intervention comparisons |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2025/08/22 14:59:13 |
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Basic information
Public title
Feasibility Study to Test the Effectiveness of Open Dialogue Training for Psychiatric Staff
Acronym
Feasibility Study to Test the Effectiveness of Open Dialogue Training for Psychiatric Staff
Scientific Title
Feasibility Study to Test the Effectiveness of Open Dialogue Training for Psychiatric Staff - single group pre- and post-intervention comparisons
Scientific Title:Acronym
Feasibility Study to Test the Effectiveness of Open Dialogue Training for Psychiatric Staff - single group pre- and post-intervention comparisons
Region
| Japan |
Condition
Condition
healthy psychiatric professionals
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A single-arm pre- and post-comparison study will be conducted to test the feasibility of an effectiveness trial of OD training for psychiatric staff.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes will be 1) study inclusion rate, 2) dropout rate, and 3) training participation rate. The study inclusion rate will be the number of participants/number of applicants, the dropout rate will be the number of dropouts/number of study subjects (study subjects who participated in training less than four times will be considered dropouts), and the training participation rate will be the number of times participated/8 times.
Key secondary outcomes
Secondary endpoints in this study were NAS (EE scale), FCJ (EE scale), SOC-13 (SOC scale), PSS (stress scale), DSS (stigma scale), SDS (social distance), PS (psychological safety scale), UWES (work engagement scale), SCS ( Self-Compassion Scale), and WHO-HPQ (Labor Productivity) at the beginning of the study (week 0), at the end of the intervention (week 8), and at follow-up (week 16), as well as the mean and standard deviation.
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
| Behavior,custom |
Interventions/Control_1
Group training once a week, 2 hours per session, for a total of 8 sessions (16 hours total) to become an Open Dialogue practitioner
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible applicants will be health care professionals who work full-time at Oouchi Hospital and meet the following selection criteria.
-Those who are medical professionals (physicians, nurses, mental health workers, licensed psychologists, clinical psychologists, occupational therapists, and physical therapists), and responsible for the care and treatment of psychiatric patients in their daily work.
-Those who are currently in good physical condition to work.
-Those who are able to participate in all training sessions.
-Those who can provide written consent to participate in the study.
Key exclusion criteria
Persons who meet the following conditions will be excluded from participation in this study
-Those who have had more than 10 hours of OD training in the past.
-Those who have obvious difficulties in following up during the study period.
-Those who, in the opinion of the principal investigator, have a serious physical or mental illness that would make it difficult for them to participate in the study.
-Those who the principal investigator determines are not appropriate to participate in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-0016
Address
35, Shinano-machi, Shinjuku-ku, Tokyo, Japan
TEL
+81-(0)3-3353-1211
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yamada |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-0016
Address
35, Shinano-machi, Shinjuku-ku, Tokyo, Japan
TEL
+81-(0)3-3353-1211
Homepage URL
yamada.masashi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Heisei Medical Welfare Group Research Institute
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Tokyo
Tel
+81-(0)3-3353-1211
med-rinri-jimu@adst.keio.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 | 19 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063102
