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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036294
Receipt No. R000041295
Scientific Title Effectiveness of return to work program for workers on sick leave due to mood disorders and stress related disorders: Before-after trial
Date of disclosure of the study information 2019/04/01
Last modified on 2019/05/17

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Basic information
Public title Effectiveness of return to work program for workers on sick leave due to mood disorders and stress related disorders: Before-after trial
Acronym Effectiveness of return to work program for workers on sick leave due to mood disorders and stress related disorders: Before-after trial
Scientific Title Effectiveness of return to work program for workers on sick leave due to mood disorders and stress related disorders: Before-after trial
Scientific Title:Acronym Effectiveness of return to work program for workers on sick leave due to mood disorders and stress related disorders: Before-after trial
Region
Japan

Condition
Condition Mood disorders, Stress related disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. Assess the effectiveness of the return to work program conducted by a multidisciplinary team incorporating occupational therapy for people with mood disorders and stress related disorders.
2. Assess the short-term effectiveness of the program for reinstatement readiness, job performance, social fitness, cognitive function, symptoms, cognitive tendency, and temperament.
3.In order to evaluate the medium- and long-term effectiveness of the program, calculate reinstatement rate at 6, 12 months after the program, and work continuation rate at 6, 12, 18, 24 months after reinstatement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes a) reinstatement readiness after the program ends (Psychiatric Rework Readiness Scale: PRRS)
Key secondary outcomes Post-program
b) symptoms (Hamilton rating scale for depression: HAM-D, Young mania rating scale: YMRS)
c) cognitive function (Brief assessment of cognition in schizophrenia: BACS)
d) cognitive tendency (Beck cognitive insight scale: BCIS)
e) temperament (Temperament evaluation of Menphis, Pisa, Paris and San Diego: TEMPS, Munich personality test: MPT)
f) social adaptation (Social adaptation self-evaluation scale: SASS)
g) job performance ability (General aptitude test battery: GATB)
h) overall function (Global assessment of functioning: GAF)
i) Return to work rate
After 6, 12, 18 and 24 months after returning to work
j) Employment continuation rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Two weekly study programs (psychological education, psychotherapy), weekly metacognitive training (D-MCT), and five times weekly occupational therapy for three months
Before reinstatement, we will have a meeting of work coordination between the rework team and the people in the workplace
The program involves doctors, clinical psychologists, mental health workers, pharmacists and occupational therapists
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
60 years-old >=
Gender Male and Female
Key inclusion criteria People
a) diagnosed with mood disorder or stress related disorder in ICD-10 by psychiatrist
b) on leave of absence who are willing to return to work, or in the process of leaving but have a strong intention to reemploy
c) attend 80% or more of occupational therapy five days a week for the past month and the average score on the PRRS is 2.0 or more
d) allowed to take part in this research by psychiatrist
Key exclusion criteria a) diagnosed with schizophrenia, intellectual disability, alcohol / drug dependence (substance abuse / dependence), dementia, epilepsy, head trauma, cerebrovascular disease
b) have no intention of reinstatement or reemployment
c) have difficulty performing cognitive function tests
d) can not obtain consent to participate in research
e) not allowed to take part in this research by psychiatrist
f) judged to be inadequate in their judgment ability due to changes in symptoms etc. during the study (after participation in the study)
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Shinsuke
Middle name
Last name Washizuka
Organization Shinshu University
Division name Department of Psychiatry, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matsumoto, Nagano
TEL 0263-37-2638
Email swashi@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Sachie
Middle name
Last name Tanaka
Organization Shinshu University
Division name Division of occupational therapy, school of health science, faculty of medicine
Zip code 8621
Address 3-1-1, Asahi, Matsumoto, Nagano
TEL 0263-37-2401
Homepage URL
Email sachifuk@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu 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 Shinshu University
Address 390
Tel 0263-37-2572
Email mdrinri@shinshu-u.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 信州大学(長野県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 06 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2024 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
2019 Year 03 Month 26 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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