UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032504
Receipt No. 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 (Ver. 4)

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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
Email 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
Email tamaki@md.tsukuba.ac.jp

Sponsor
Institute Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037069