UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036294
Receipt number 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 16:40:50

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.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