UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052155 |
|---|---|
| Receipt number | R000059526 |
| Scientific Title | Effects of a video viewing intervention with positive-word stimulation on depressive symptoms in elderly cardiovascular patients with subthreshold depression: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/09/09 18:38:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of a video viewing intervention with positive-word stimulation on depressive symptoms in elderly cardiovascular patients with subthreshold depression: a pilot randomized controlled trial
Acronym
Effects of a video viewing intervention with positive-word stimulation on depressive symptoms in elderly cardiovascular patients with subthreshold depression: a pilot randomized controlled trial
Scientific Title
Effects of a video viewing intervention with positive-word stimulation on depressive symptoms in elderly cardiovascular patients with subthreshold depression: a pilot randomized controlled trial
Scientific Title:Acronym
Effects of a video viewing intervention with positive-word stimulation on depressive symptoms in elderly cardiovascular patients with subthreshold depression: a pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Cardiovascular disease patients with subthreshold depression
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Depression and heart disease are two diseases that generally affect a large number of people; depression is projected to be the second leading cause of the global burden of disease through 2030, and ischemic heart disease is projected to be the third. In addition, patients with depressive symptoms have a higher relative risk of myocardial infarction (1.5 to 4.5 times) compared to patients with depressive symptoms and those without depressive symptoms. Furthermore, depressed patients with cardiac disease are known to have an increased risk of cardiovascular events such as myocardial infarction and rehospitalization, as well as an increased risk of death.
Cardiac rehabilitation for cardiac patients includes a comprehensive program of exercise therapy, dietary and smoking guidance, and psychological support to improve lipid and weight loss, exercise tolerance, reduce depressive symptoms, improve quality of life, and decrease mortality. However, only a small percentage of cardiac patients with depressive symptoms receive comprehensive programs.
Preventive interventions for patients with subthreshold depression, the pre-depressive stage of depression, have been found to significantly reduce the incidence of depression compared to those without intervention. In addition, an intervention using video viewing on the Internet as one of the preventive interventions for depression has been found to reduce depressive symptoms, but the effect of a short-term intervention using video viewing on the Internet in cardiac patients with subthreshold depression has not been determined.
The purpose of this study was to determine the impact of an intervention using web-based video viewing on depressive symptoms in cardiac patients with subthreshold depression admitted to an acute care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in scores on the Japanese version of the Beck Depression Inventory-Second Edition one week after the baseline assessment.
Key secondary outcomes
Secondary outcomes are change in the minimum amount of exercise at which heart failure symptoms appear on the Specific Activity Scale, New York Heart Association functional class, and change in handgrip strength one week after the baseline assessment.
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
In addition to general rehabilitation (muscle strengthening exercises, exercise therapy, daily living exercises, daily living guidance, etc.) in the acute care unit, the intervention group will access the SPSRS website, select videos of interest, and watch 10-minute videos once a day, five times a week for one week.
Interventions/Control_2
The control group will receive general rehabilitation in an acute care ward (muscle strengthening exercises, exercise therapy, daily living exercises, daily living guidance, etc.) In addition, after accessing the YouTube website, they will select videos of interest and watch a 10-minute video once a day, five times a week for one week.
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
The selection criteria were as follows: patients 65 years of age or older admitted to the acute care ward of with cardiac disease (myocardial infarction, coronary revascularization, angina pectoris, heart failure, valvular heart disease, atrial or ventricular arrhythmia), with a total score of at least 10 points on the Japanese version of the Beck Depression Inventory-Second Edition, and had a total score of at least 10 points on the Japanese version of the Beck Depression Inventory-Second Edition and a New York Heart Association cardiac function classification of degree I to III. The subjects had sufficient cognitive ability to understand the content and purpose of the study and to provide written consent prior to participation in the study.
Key exclusion criteria
Exclusion criteria were those who had been diagnosed with a mental disorder at least once in their lifetime regardless of the type of disorder, those who were currently receiving professional treatment for mental health problems, those with visual or hearing impairments that interfere with daily living, those who were assessed by M.I.N.I. to have had a major depressive episode in the past two weeks, and those with life The exclusion criteria were: those with serious life-threatening complications.
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
371-8514
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 | Masataka |
| Middle name | |
| Last name | Sakimoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma, Japan
TEL
027-220-8952
Homepage URL
h231c010@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
Ethical Review Board for Medical Research Involving Human Subjects of Gunma University
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
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059526
