UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045030 |
|---|---|
| Receipt number | R000051435 |
| Scientific Title | A preliminary Study on effect of environment on the effectiveness of psychotherapy |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/03 08:23:25 |
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Basic information
Public title
A preliminary Study on effect of environment on the effectiveness of psychotherapy
Acronym
A preliminary Study on effect of environment on the effectiveness of psychotherapy
Scientific Title
A preliminary Study on effect of environment on the effectiveness of psychotherapy
Scientific Title:Acronym
A preliminary Study on effect of environment on the effectiveness of psychotherapy
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate how environmental changes in the clinic room affect the treatment of major depressive disorder (depression).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in change in depressive symptoms between groups with and without forest environment (HAM-D)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Therapeutic environment(woodification)
Interventions/Control_2
Therapeutic environment(usual)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who can understand the consent document and can make their own decisions.
2) Patients who meet the diagnostic criteria for mood disorders in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
3) Patients who are between 20 and 80 years of age at the time of participation in the study.
Key exclusion criteria
1) Patients with a history of psychotic episode, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), or eating disorder
2) Patients with drug or alcohol dependence
3) Patients with impaired judgment due to psychiatric symptoms
4) Patients who do not like the forest environment or are allergic to it.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University Schoolo of Medicine
Division name
Department of Psychiatry
Zip code
105-0003
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
kodaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University Schoolo of Medicine
Division name
Department of Psychiatry
Zip code
105-0003
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University Schoolo of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Forestry Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sumitomo Forestry Co., Ltd.
BrainEnergy Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University Schoolo of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
kodaka@jikei.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
| 2021 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051435
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
