UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034372 |
|---|---|
| Receipt number | R000039181 |
| Scientific Title | The elucidation of the stress mechanism of employees on sick leave due to depression, and the effect of the return-to-work program using cognitive behavior therapy |
| Date of disclosure of the study information | 2018/10/04 |
| Last modified on | 2022/04/07 16:15:21 |
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Basic information
Public title
The elucidation of the stress mechanism of employees on sick leave due to depression, and the effect of the return-to-work program using cognitive behavior therapy
Acronym
Return-to-work program using Cognitive Behavior Group Therapy for employees on sick leave due to depression
Scientific Title
The elucidation of the stress mechanism of employees on sick leave due to depression, and the effect of the return-to-work program using cognitive behavior therapy
Scientific Title:Acronym
Return-to-work program using Cognitive Behavior Group Therapy for employees on sick leave due to depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify that stress of employees on sick leave due to depression using psychological and biological parameters. We also examine to the efficacy of the cognitive behavior group therapy for the return-to-work of employees on sick leave due to depression using psychological and biological parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Cortisol, CRP
Key secondary outcomes
Montgomery Asberg Depression Rating Scale(MADRS)
Patient Health Questionnaire (PHQ-9)
Clinical Global Impression(CGI)
Behavior Activation for Depression Scale
Environmental Reward Observation Scale
Dysfunctional Attitude Scale 24(DAS24)
Difficulties in Returning to Work Inventory (DRW)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Coginive behavior group therapy, once a week , 10weeks (about 3 months)
Interventions/Control_2
Treatment as usual(TAU)
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
(a) 20-65 years old male or female,
(b) a diagnosis of major depressive disorder for the current or past episode established by a psychiatrist or a clinical psychologist using the Structured Clinical Interview for DSM-4(SCID),
(c)Informed consent is obtained,
(d)When the persons are under going to other hospital expect Omiya Suzunoki clinic, only them can participate in cognitive behavior group therapy who brings a letter of introduction after permission of participant the treatment by their
attending physicians.
Key exclusion criteria
current or previous diagnosis of a psychotic spectrum disorder, evidence of organic brain disorder, mental retardation, personality disorder, current high risk of suicide, substance abuse, or serious somatic disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Matsunaga |
Organization
Rikkyo University
Division name
Department of Psychology
Zip code
3528558
Address
1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL
048-471-7069
mikim@rikkyo.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Matsunaga |
Organization
Rikkyo University
Division name
Department of Psychology
Zip code
3528558
Address
1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL
048-471-6901
Homepage URL
mikim@rikkyo.ac.jp
Sponsor or person
Institute
Rikkyo University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rikkyo University
Address
3-34-1, NishiIkebukuro, Toshima, Tokyo
Tel
03-3985-4589
lifescience@rikkyo.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
大宮すずのきクリニック（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039181
