UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056093 |
|---|---|
| Receipt number | R000064080 |
| Scientific Title | Effects of a video viewing intervention with positive ward stimulation on depressive symptoms in older adults with subthreshold depression |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/11 19:23:08 |
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Basic information
Public title
Effects of a video viewing intervention with positive ward stimulation on depressive symptoms in older adults with subthreshold depression
Acronym
Effects of a video viewing intervention with positive ward stimulation on depressive symptoms in older adults with subthreshold depression
Scientific Title
Effects of a video viewing intervention with positive ward stimulation on depressive symptoms in older adults with subthreshold depression
Scientific Title:Acronym
Effects of a video viewing intervention with positive ward stimulation on depressive symptoms in older adults with subthreshold depression
Region
| Japan |
Condition
Condition
older adults with subthreshold depression
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In today's aging society, mental health issues among the older adults are becoming an increasingly important concern. Subthreshold depression does not meet the diagnostic criteria for clinical depression, but has been noted to increase the risk of progression to severe depression. Additionally, depression is often reported to negatively impact the quality of life and physical health of older adults.
Preventive interventions for patients with subthreshold depression, a precursor to depression, have been shown to significantly reduce the incidence of depression compared to patients who do not receive the intervention. In addition, a video viewing intervention using Subliminal Priming with Supraliminal Reward Stimulation (SPSRS) as one of the preventive interventions for depression has been shown to reduce depressive symptoms. Previous studies have focused on young adults with subthreshold depression, and the short-term intervention effects of video viewing with SPSRS on older adults with subthreshold depression have not been determined.
Therefore, this study will examine the effects of a video viewing intervention using the SPSRS on depressive symptoms in older adults with subthreshold depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in Geriatric Depression Scale 15 after the 3-week intervention.
Key secondary outcomes
Secondary outcome is the change in Medical Outcome Study 8-Item Short-Form Health Survey after 3-week intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group watch videos on SPSRS for about 3 minutes at a time, once a day, 5 times a week, for 3 weeks.
Interventions/Control_2
The control group watch videos on YouTube for about 3 minutes at a time, once a day, 5 times a week, for 3 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria were inpatients 65 years of age or older, with a Geriatric Depression Scale 15 score of 5 or higher, with sufficient cognitive ability to understand the content and purpose of the study, and who were able to give written consent prior to participation in the study.
Key exclusion criteria
Exclusion criteria were those with visual or hearing impairment at a level that would cause problems in daily living, and those who were assessed by The Mini-International Neuropsychiatric Interview as having had a major depressive episode in the past 2 weeks.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Hirao |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
3718514
Address
3-39-22 Showa, Maebashi, Gunma, Japan
TEL
027-220-8952
kazuki.hirao@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Shimada |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
3718514
Address
3-39-22 Showa, Maebashi, Gunma, Japan
TEL
027-220-8952
Homepage URL
h241c006@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Ethics review committee for medical research involving human subjects
Address
3-39-15 Showa, Maebashi, Gunma, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2024 | Year | 11 | Month | 08 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064080
