UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058947 |
|---|---|
| Receipt number | R000067408 |
| Scientific Title | Efficacy of a video viewing website offering positive word stimulation on depressive symptoms in people with subthreshold depression: a randomized controlled trial |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/05 21:57:01 |
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Basic information
Public title
Efficacy of a video viewing website offering positive word stimulation on depressive symptoms in people with subthreshold depression: a randomized controlled trial
Acronym
Efficacy of a video viewing website offering positive word stimulation on depressive symptoms in people with subthreshold depression
Scientific Title
Efficacy of a video viewing website offering positive word stimulation on depressive symptoms in people with subthreshold depression: a randomized controlled trial
Scientific Title:Acronym
Efficacy of a video viewing website offering positive word stimulation on depressive symptoms in people with subthreshold depression
Region
| Japan |
Condition
Condition
Subthreshold depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to clarify the effect of a video-viewing website (SPSRS) presenting positive verbal stimuli on depressive symptoms in people with subthreshold depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome will be the change in the scores on the Japanese version of the Center for Epidemiologic Studies Depression Scale (CES-D) at 5 weeks after the baseline assessment.
Key secondary outcomes
Secondary outcomes are changes in the Japanese version of the Kessler Screening Scale for Psychological Distress (K-6) and the Japanese version of the Generalized Anxiety Disorder 7-item scale (GAD-7) at 5 weeks after baseline assessment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The experimental group uses SPSRS, a website that presents positive word stimulation through videos, and watches videos for 10 minutes per day, 7 days a week, for 5 weeks.
Interventions/Control_2
The waiting-list control group will not receive the intervention during the 5-week intervention period. If participants express interest, the video viewing intervention using SPSRS will be provided after the 5-week assessment period concludes.
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals with a CES-D score of 16 or higher
(2) Individuals who own a smartphone
(3) Individuals providing electronic informed consent prior to trial participation
Key exclusion criteria
(1) Individuals with a lifetime history of mental illness
(2) Individuals currently receiving treatment from a mental health professional for mental health issues
(3) Individuals with visual or auditory impairments that adversely affect daily life
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Kurashiki Heisei Hospital
Division name
Department of Rehabilitation
Zip code
710-0826
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
TEL
086-427-1111
hiroyukiuchida02@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | uchida |
Organization
Kurashiki Heisei Hospital
Division name
Department of Rehabilitation
Zip code
710-0826
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
TEL
086-427-1111
Homepage URL
hiroyukiuchida02@gmail.com
Sponsor or person
Institute
Kurashiki Heisei Hospital
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
The Ethics Committee of Kurashiki Heisei Hospital
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
Tel
086-427-1111
hiroyukiuchida02@gmail.com
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
| 2025 | Year | 09 | Month | 05 | 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
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067408
