UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032504 |
|---|---|
| Receipt number | R000037069 |
| Scientific Title | Research on practice and efficacy of Open Dialogue Approach in employment transition support facility |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2020/03/06 15:04:34 |
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Basic information
Public title
Research on practice and efficacy of Open Dialogue Approach in employment transition support facility
Acronym
Open Dialogue Approach in employment transition support facility
Scientific Title
Research on practice and efficacy of Open Dialogue Approach in employment transition support facility
Scientific Title:Acronym
Open Dialogue Approach in employment transition support facility
Region
| Japan |
Condition
Condition
Depression, Developmental disorder, Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine feasibility and efficacy of Open Dialogue approach in job support for patients with psychiatric disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
semi-structured interview for patients and staff
Key secondary outcomes
questionnaire survey for patients and staff
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Open Dialogue Approach
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who participating in employment transition support serivice
2.Those who has permission to work by the attending physician
3.Those who live in the catchment area of the participating centers
4.Those who can visit Employment transition support facility twice a week
5.Native Japanese speaker
Key exclusion criteria
1.Those who can confirm the suicide attempt
2. Those who can confirm suicidal idea and have concrete plans of suicide
3.Those who have too severe cognitive dysfunctions to do Open dialogue sessions
4.Physical disease that may interfere psychological treatment
5.Those who have already received open dialogue, or currently receive other structured psychotherapy
6. Those who are judged by the screening doctors due to other reasons, such as pregnant, difficulty in understanding the procedure of the study or treatment protocol due to illiteracy or intellectual problem, ongoing or scheduled court litigation for which Open Dialogue session works favorably (excluding arbitration or litigation for divorce), and etc.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tamaki |
| Middle name | |
| Last name | Saito |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
TEL
029-853-3099
tamaki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Saito |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
TEL
029-853-3099
Homepage URL
tamaki@md.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
LITALICO Inc.
Name of secondary funder(s)
LITALICO Inc.
IRB Contact (For public release)
Organization
Medical Ethics Committee for University of Tsukuba
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
リタリコ株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
22
Results
Open dialogue was received by 12 people with disabilities, and 14 staff members implemented it.
As a result of comparison before and after, K6 (t (7) = 0.80 n.s d = .21), SOC-13 (t (7) = 2.68 p <.05 d = .62), a scale for Measuring Help-Seeking Styles (t (7) = 3.864 p <.01 d = 1.68), EROS (t (7) = 2.01 p <.10 d = .63), number of days of using the employment transfer support service (t (7) = 2.04 p <.10 d =. 98), the absence rate of the employment transfer support service (t (7) = 2.24 p <.10 d = .56).
Results date posted
| 2020 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Users of employment support facilities for persons with disabilities
Staff of employment support facilities for persons with disabilities
Participant flow
Before and after the intervention in the open dialogue, the researcher conducted a questionnaire for the survey participants. In addition, after the implementation period of the open dialogue, the surveyor interviewed the surveyed subjects.
Adverse events
No Adverse events.
Outcome measures
K6
SOC-13
EROS
a scale for Measuring Help-Seeking Styles
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037069
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| Registered date | File name |
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