UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046917 |
|---|---|
| Receipt number | R000053528 |
| Scientific Title | The mood-enhancing effect of viewing images of the natural environment in major depression and anxiety disorders |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/07/08 14:01:59 |
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Basic information
Public title
The mood-enhancing effect of viewing images of the natural environment in major depression and anxiety disorders
Acronym
The mood-enhancing effect of viewing images of the natural environment in major depression and anxiety disorders
Scientific Title
The mood-enhancing effect of viewing images of the natural environment in major depression and anxiety disorders
Scientific Title:Acronym
The mood-enhancing effect of viewing images of the natural environment in major depression and anxiety disorders
Region
| Japan |
Condition
Condition
depressive disorder, anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of viewing images of natural environment on mood and brain activations in patients with depression and anxiety disorders. Furthermore, to investigate the moderating effect of symptoms of depression and anxiety, cognitive functions on the effect of viewing images of natural environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Mood immediate after intervention evaluated by visual analog scale
2) Brain activations during intervention as evaluated by NIRS
Key secondary outcomes
1) Heart rate and heart rate variability during intervention
2) The association between mood and brain activations
3) The influence of personal characteristics such as mental health states and cognitive functions on the effect of viewing the image of natural environment (eg, the more severe the depression, the greater the effect of viewing images)
4) Relationships among other personal characteristics
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Images of green natural environments such as forest, countryside, etc. are presented on a 27-inch high-resolution display for 3 minutes.
Interventions/Control_2
Images of artificial environments such as cities are presented on a 27-inch high-resolution display for 3 minutes.
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) Being diagnosed as having a depressive disorder or anxiety disorder based on DSM-5.
2) Age is 20 to 65 at the time of obtaining consent.
3) No color vision deficiency and having visual acuity (corrected visual acuity is also possible) of 0.6 or more, or no effect of vision problems on daily activities, by self-declaration (colored glasses are not allowed).
4) Right-handed.
5) A person who, after receiving a sufficient explanation before participating in this research, has a sufficient understanding and provided informed consent.
Key exclusion criteria
1) Having strong suicide ideation.
2) Those who are judged to be unsuitable as research subjects by the researcher in charge of the experimental sessions (for example, those who cannot conduct the experiments smoothly due to physical illness).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Nakagawa |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836222254
brain@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Chong |
| Middle name | |
| Last name | Chen |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
755-8505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836222254
Homepage URL
brain@yamaguchi-u.ac.jp
Sponsor or person
Institute
Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital Institutional Review Board
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
Tel
0836-22-2428
clin_res@yamaguchi-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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053528
