UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017163 |
|---|---|
| Receipt number | R000019904 |
| Scientific Title | Development of resilient role model for depression in the workplace: verification of effects on low intensity cognitive behavioral therapy program for return to work in major depressive disorder and adjustment disorders. |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2024/05/21 17:12:40 |
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Basic information
Public title
Development of resilient role model for depression in the workplace: verification of effects on low intensity cognitive behavioral therapy program for return to work in major depressive disorder and adjustment disorders.
Acronym
Development of resilient role model for depression in the workplace
Scientific Title
Development of resilient role model for depression in the workplace: verification of effects on low intensity cognitive behavioral therapy program for return to work in major depressive disorder and adjustment disorders.
Scientific Title:Acronym
Development of resilient role model for depression in the workplace
Region
| Japan |
Condition
Condition
Major Depressive Disorder, Adjustment Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the low intensity cognitive behavioral therapy program combined with medication, work-directed intervention for return-to-workers in major depressive disorder and adjustment disorders generally.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Social Adaptation Self-evaluation Scale Japanese version [SASS-J]
2) Stanford Presenteeism Scale [SPS]
Key secondary outcomes
1) Patient Health Questionnaire-9
[PHQ-9]
2) Beck Depression Inventory-Second Edition [BDI-II]
3) Connor-Davidson Resilience Scale 10 [CD-RISC10]
4) Recurrence of sickness absence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Program of 6 times in 8 weeks by internet-based CBT with self-training mainly
Interventions/Control_2
Health guidance once with a reference material
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) Workers with 4 weeks to 1 years after return to work, taking medication and work-directed intervention
2) Subjects with DSM-5 Major Depressive Disorder or Adjustment disorders in reason for sick absence
3) 5<= PHQ-9 <=14 at entry to the study
4) SASS-J <=34 at entry to the study
5) Subjects with necessity of self-care training decided by either occupational health physician or attending doctor.
6) Subjects with understanding of attending doctor as to participate in the program
Key exclusion criteria
1) Care of counseling at entry to the study
2) Subjects with irrelevance (subjects with other psychiatric disorders) and serious suicidal ideation decided by either occupational health physician or attending doctor.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Utsunomiya |
Organization
University of Occupational and Environmental Health
Division name
Department of Psychiatry
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-691-7253
k-utsu@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Utsunomiya |
Organization
University of Occupational and Environmental Health
Division name
Department of Psychiatry
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-691-7253
Homepage URL
k-utsu@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
Tel
093-603-1611
osiotaro@pub.uoeh-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 21 | 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
| 2015 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019904
