Suicidal IdeationVR-LIFE-SINCT06856083
Gamified VR Sports for Elderly Suicidal Ideation
A study testing Gamified Virtual Reality Sports Exercise Program and Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts in people with Suicidal Ideation and Depression, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
Detailed Description: This quasi-experimental study investigates the effectiveness of a gamified sports exercise intervention delivered through virtual reality (VR) to improve mental health and life expectancy in elderly individuals aged 60 and over who are experiencing suicidal thoughts. Read more about this study
- Who is it for?
- Ages 58 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Depression, Mental Health Issue
- What is being tested?
- Gamified Virtual Reality Sports Exercise Program and Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIran
- Study dates
- 14 Oct 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly men aged 60 years and older
- Suicidal thoughts confirmed by psychological evaluation
- Symptoms of depression and loneliness
- Informed consent provided by participant or family
- Residency in Tehran, Iran
Who cannot join
- Severe cognitive impairment or dementia
- Current therapeutic interventions for suicidal ideation or mental health issues
- Acute medical conditions requiring immediate attention
- History of severe substance abuse or dependence
- Significant physical disabilities preventing basic physical activity
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Physical Education and Sport Science, Faculty of Humanities and Literature, Sanandaj Branch, Islamic Azad University, Sanandaj, Iran.
Sanandaj, Kurdistan Province, 6616947455
About this study
Official title: Development of Innovative Strategies for Improving Life Satisfaction in Elderly With Suicidal Ideation: The Impact of Gamified VR Sports Training
Detailed Description:
This quasi-experimental study investigates the effectiveness of a gamified sports exercise intervention delivered through virtual reality (VR) to improve mental health and life expectancy in elderly individuals aged 60 and over who are experiencing suicidal thoughts. The study aims to address the following research questions:
Read more
How do gamified sports exercises in a virtual reality environment impact the mental health of elderly individuals with suicidal thoughts? What differences in mental health outcomes are observed between participants engaging in gamified VR exercises and those participating in conventional sports exercises?
The study design involves two groups:
Experimental Group: Participants will engage in VR-based sports training sessions that incorporate gamification elements, such as rewards, competition, and interactive challenges.
Control Group: Participants will participate in traditional sports exercises without gamification or VR components.
Procedures:
Baseline Assessment: All participants will complete a life expectancy questionnaire and standardized mental health assessments to establish baseline data.
Intervention:
The experimental group will undergo a series of VR-based sports training sessions, designed to be engaging and immersive, with gamified elements to enhance motivation and adherence.
The control group will participate in conventional sports exercises, such as light aerobic activities or stretching, delivered in a standard, non-gamified format.
Post-Intervention Assessment: Mental health outcomes, including changes in suicidal ideation, life satisfaction, and overall well-being, will be evaluated using validated questionnaires and scales.
Expected Outcomes:
The study hypothesizes that the experimental group will demonstrate significant improvements in mental health outcomes, including reduced suicidal ideation and increased life satisfaction, compared to the control group. The findings aim to provide evidence-based insights into the potential of gamified VR interventions as a non-pharmacological strategy to enhance the well-being of elderly individuals at risk for suicide.
This study contributes to the growing body of research on innovative approaches to mental health support for vulnerable populations, with a focus on leveraging technology to improve quality of life and reduce suicide risk among the elderly.
Read the detailed description
Detailed Description
Background Aging is associated with an increased incidence of chronic diseases and mental health issues, including depression and suicidal ideation. Elderly individuals (aged 60 and over) represent a vulnerable population at heightened risk for suicide. Research indicates that physical activity plays a crucial role in improving both mental and physical health outcomes. However, many elderly individuals encounter significant barriers to regular participation in physical exercises, such as low motivation and limited access to facilities.
Emerging technologies, such as gamification and virtual reality (VR), have shown promise in enhancing engagement in health-related behaviors. Gamification-integrating game-like elements into non-game contexts-has been recognized as a potent tool to motivate individuals to participate in physical activities. VR offers an immersive experience that may further enhance the appeal of physical exercises for older adults.
Purpose This study aims to evaluate the effectiveness of a gamified sports exercise program in a virtual reality environment as a means to improve mental health and life satisfaction among elderly individuals experiencing suicidal ideation. The intervention seeks to create an engaging and supportive environment to reduce suicidal ideation and increase overall life satisfaction within this demographic.
Study Design This is a quasi-experimental study with pre-test and post-test assessments. Participants will be randomly assigned to either an experimental group that engages in VR-based sports exercises or a control group that participates in conventional sports activities without gamified elements.
Intervention
Participants in the experimental group will engage in sports exercises designed in a virtual reality environment, incorporating gamification elements to enhance engagement. The intervention includes:
Structured virtual reality sports sessions guided by trained facilitators.
Gamified features such as rewards, points, and friendly competition to stimulate motivation.
Social interaction elements where participants can engage with each other during sessions to foster community and support.
The control group will participate in traditional physical activity sessions without VR or gamification.
Assessments
Baseline assessments will be conducted before the interventions, with follow-up assessments after the 8-week intervention period. The following tools will be utilized:
Life Expectancy Questionnaire: A validated tool to assess participants' perceptions of their future and overall well-being.
Suicidal Ideation Scale: A standard scale to measure the severity of suicidal thoughts.
Depression Inventory: To assess levels of depressive symptoms before and after the intervention.
Data Analysis Data will be analyzed using appropriate statistical methods to assess the effectiveness of the gamified sports exercise program compared to conventional exercises. Primary outcomes will focus on changes in mental health indicators, including suicidal ideation, life expectancy perceptions, and overall quality of life.
Expected Outcomes
The study anticipates that participation in the gamified virtual reality sports exercises will lead to:
A significant reduction in suicidal thoughts and depressive symptoms among participants.
Improved perceptions of life expectancy among elderly individuals.
Higher rates of physical activity engagement in the experimental group compared to the control group.
Significance The findings of this study are expected to contribute valuable knowledge to the field of elderly mental health, particularly for strategies aimed at reducing suicide risks. By addressing the interplay of mental health and physical activity, the research aims to provide evidence for innovative intervention strategies that can enhance the quality of life for vulnerable elderly populations.
Ethical Considerations The study will adhere to ethical guidelines for research. Informed consent will be obtained from all participants (or their guardians) before enrollment, ensuring they fully understand the study's purpose, procedures, and their right to withdraw at any time.
Key Changes:
Removed Duplicate Information:
Removed eligibility criteria and sample size details, as these are recorded in other data elements.
Focused on providing extended technical details about the intervention, assessments, and data analysis.
Technical and Extended Description:
Added more technical details about the VR-based sports exercises, gamification elements, and assessment tools.
Ensured the description aligns with the protocol's purpose and design without repeating information from other sections.
Improved Flow and Readability:
Organized content into clear sections for better readability and alignment with protocol requirements.
- Conditions
- Suicidal Ideation, Depression, Mental Health Issue
- Being tested
- Gamified Virtual Reality Sports Exercise Program, Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts
- Keywords
- Gamified virtual reality exercises, Elderly mental health, Suicidal thoughts intervention, Physical activity in older adults, VR sports training, Depression reduction, Life expectancy improvement, Quasi-experimental study, Non-pharmacological intervention, Interactive exercise program, Mental health support for seniors, Gamification in healthcare, Elderly population study, Community engagement through exercise, Innovative health interventions
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Virtual Reality Sports Exercise ProgramBehavioural
Also called VR-Based Gamified Exercise Program, Immersive VR Sports Training for Elderly, Virtual Reality Gamification for Mental Health
Participants in the experimental group will participate in a variety of sports exercises designed in a virtual reality environment utilizing gamification elements to enhance engagement. The intervention will include:
- Structured virtual reality sports sessions guided by specially trained facilitators.
- Use of gamified features such as rewards, points, and friendly competition to stimulate motivation.
- Incorporation of social elements where participants can interact with each other during sessions to foster community and support.
Traditional Sports Exercise Program for Elderly Individuals with Suicidal ThoughtsBehavioural
Also called Conventional Physical Activity Program, Low-Impact Sports for Elderly, Group-Based Exercise for Mental Health
participants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement.
The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected.
| Study group | Role | What they receive |
|---|---|---|
| Gamified Virtual Reality Sports Exercise Program for Elderly Individuals with Suicidal Thoughts | Experimental | Participants will engage in a gamified virtual reality (VR) sports exercise program specifically designed for elderly individuals experiencing suicidal thoughts. The intervention consists of structured, immersive VR sessions that incorporate various sports activities tailored to accommodate the physical abilities of the participants. These sessions will utilize gamification elements, including points, rewards, and friendly competition, to enhance motivation and engagement.
Participants will join weekly VR exercise sessions guided by trained facilitators who will provide support and encouragement throughout the program. The aim is to foster social interaction among participants, creating a sense of community and reducing feelings of loneliness. Each session will last approximately 60 minutes and will include warm-up exercises, the main VR activity, and a cooldown Receives: Behavioral: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts |
| Active Comparator: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thought | Experimental | Participants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement.
The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected.
Behavioral: Traditional Sports Exercise Program Structured physical activity sessions led by experienced facilitators. Low-impact sports and exercises tailored for older adults. Receives: Behavioral: Gamified Virtual Reality Sports Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicidal Ideation as Measured by the Beck Scale for Suicide Ideation (BSSI)
Description: The Beck Scale for Suicide Ideation (BSSI) is a validated 21-item questionnaire used to assess the intensity and frequency of suicidal thoughts. Scores range from 0 to 38, with higher scores indicating greater severity of suicidal ideation. This measure will be administered at baseline and after 2 months of participation to evaluate changes in suicidal ideation among elderly participants.
Measured: Baseline and post-intervention (2 months).
Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 (PHQ-9)
Description: The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item questionnaire used to assess the severity of depressive symptoms based on DSM-5 criteria. Scores range from 0 to 27, with higher scores indicating more severe depression. This measure will be administered at baseline and after 2 months of participation to evaluate changes in depressive symptoms among elderly participants.
Measured: Baseline and post-intervention (2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start14 Oct 2023
- Primary completion25 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a quasi-experimental interventional model designed to evaluate the impact of gamified virtual reality sports exercises on mental health and life expectancy in elderly individuals (aged 60 and over) experiencing suicidal thoughts. Participants will be randomly assigned to either the experimental group, which will engage in VR-based sports training sessions utilizing gamification elements, or the control group, which will participate in conventional sports exercises without immersive technology or gamification. The intervention aims to enhance physical activity engagement through an interactive and supportive environment, fostering community and social interaction among participants. Data will be gathered through baseline assessments and follow-up evaluations to gauge changes in mental health indicators, including suicidal ideation and perceived life expectancy.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zinat Ebrahimi, Islamic Azad University, Sanandaj
- Investigators
- Zinat Dr Zinat Ebrahimi, Professor, Principal investigator, Islamic Azad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856083
- Sponsor's protocol ID
- VR-LIFE-SI-2025
- Acronym
- VR-LIFE-SI
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to persistent technical difficulties in providing a functional web address for the IPD sharing plan on the clinical trial site, interested parties are encouraged to contact zin368@gmail.com for further information. We have encountered issues that prevent the proper display or access of the sharing link, necessitating this alternative means of communication.
Publications
Chambers, L.W. and L.W. Chambers, Prevalence and monetary costs of dementia in Canada. 2016: Miscellaneous Agency.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Innovative Strategies for Improving Life Satisfaction in Elderly With Suicidal Ideation: The Impact of Gamified VR Sports Training
- ClinicalTrials.gov ID
- NCT06856083
- Acronym / sponsor ID
- VR-LIFE-SI / VR-LIFE-SI-2025
- Conditions
- Suicidal Ideation, Depression, Mental Health Issue
- Keywords
- Gamified virtual reality exercises, Elderly mental health, Suicidal thoughts intervention, Physical activity in older adults, VR sports training, Depression reduction, Life expectancy improvement, Quasi-experimental study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detailed Description:
This quasi-experimental study investigates the effectiveness of a gamified sports exercise intervention delivered through virtual reality (VR) to improve mental health and life expectancy in elderly individuals aged 60 and over who are experiencing suicidal thoughts. The study aims to address the following research questions:
How do gamified sports exercises in a virtual reality environment impact the mental health of elderly individuals with suicidal thoughts? What differences in mental health outcomes are observed between participants engaging in gamified VR exercises and those participating in conventional sports exercises?
The study design involves two groups:
Experimental Group: Participants will engage in VR-based sports training sessions that incorporate gamification elements, such as rewards, competition, and interactive challenges.
Control Group: Participants will participate in traditional sports exercises without gamification or VR components.
Procedures:
Baseline Assessment: All participants will complete a life expectancy questionnaire and standardized mental health assessments to establish baseline data.
Intervention:
The experimental group will undergo a series of VR-based sports training sessions, designed to be engaging and immersive, with gamified elements to enhance motivation and adherence.
The control group will participate in conventional sports exercises, such as light aerobic activities or stretching, delivered in a standard, non-gamified format.
Post-Intervention Assessment: Mental health outcomes, including changes in suicidal ideation, life satisfaction, and overall well-being, will be evaluated using validated questionnaires and scales.
Expected Outcomes:
The study hypothesizes that the experimental group will demonstrate significant improvements in mental health outcomes, including reduced suicidal ideation and increased life satisfaction, compared to the control group. The findings aim to provide evidence-based insights into the potential of gamified VR interventions as a non-pharmacological strategy to enhance the well-being of elderly individuals at risk for suicide.
This study contributes to the growing body of research on innovative approaches to mental health support for vulnerable populations, with a focus on leveraging technology to improve quality of life and reduce suicide risk among the elderly.
Detailed description
Detailed Description
Background Aging is associated with an increased incidence of chronic diseases and mental health issues, including depression and suicidal ideation. Elderly individuals (aged 60 and over) represent a vulnerable population at heightened risk for suicide. Research indicates that physical activity plays a crucial role in improving both mental and physical health outcomes. However, many elderly individuals encounter significant barriers to regular participation in physical exercises, such as low motivation and limited access to facilities.
Emerging technologies, such as gamification and virtual reality (VR), have shown promise in enhancing engagement in health-related behaviors. Gamification-integrating game-like elements into non-game contexts-has been recognized as a potent tool to motivate individuals to participate in physical activities. VR offers an immersive experience that may further enhance the appeal of physical exercises for older adults.
Purpose This study aims to evaluate the effectiveness of a gamified sports exercise program in a virtual reality environment as a means to improve mental health and life satisfaction among elderly individuals experiencing suicidal ideation. The intervention seeks to create an engaging and supportive environment to reduce suicidal ideation and increase overall life satisfaction within this demographic.
Study Design This is a quasi-experimental study with pre-test and post-test assessments. Participants will be randomly assigned to either an experimental group that engages in VR-based sports exercises or a control group that participates in conventional sports activities without gamified elements.
Intervention
Participants in the experimental group will engage in sports exercises designed in a virtual reality environment, incorporating gamification elements to enhance engagement. The intervention includes:
Structured virtual reality sports sessions guided by trained facilitators.
Gamified features such as rewards, points, and friendly competition to stimulate motivation.
Social interaction elements where participants can engage with each other during sessions to foster community and support.
The control group will participate in traditional physical activity sessions without VR or gamification.
Assessments
Baseline assessments will be conducted before the interventions, with follow-up assessments after the 8-week intervention period. The following tools will be utilized:
Life Expectancy Questionnaire: A validated tool to assess participants' perceptions of their future and overall well-being.
Suicidal Ideation Scale: A standard scale to measure the severity of suicidal thoughts.
Depression Inventory: To assess levels of depressive symptoms before and after the intervention.
Data Analysis Data will be analyzed using appropriate statistical methods to assess the effectiveness of the gamified sports exercise program compared to conventional exercises. Primary outcomes will focus on changes in mental health indicators, including suicidal ideation, life expectancy perceptions, and overall quality of life.
Expected Outcomes
The study anticipates that participation in the gamified virtual reality sports exercises will lead to:
A significant reduction in suicidal thoughts and depressive symptoms among participants.
Improved perceptions of life expectancy among elderly individuals.
Higher rates of physical activity engagement in the experimental group compared to the control group.
Significance The findings of this study are expected to contribute valuable knowledge to the field of elderly mental health, particularly for strategies aimed at reducing suicide risks. By addressing the interplay of mental health and physical activity, the research aims to provide evidence for innovative intervention strategies that can enhance the quality of life for vulnerable elderly populations.
Ethical Considerations The study will adhere to ethical guidelines for research. Informed consent will be obtained from all participants (or their guardians) before enrollment, ensuring they fully understand the study's purpose, procedures, and their right to withdraw at any time.
Key Changes:
Removed Duplicate Information:
Removed eligibility criteria and sample size details, as these are recorded in other data elements.
Focused on providing extended technical details about the intervention, assessments, and data analysis.
Technical and Extended Description:
Added more technical details about the VR-based sports exercises, gamification elements, and assessment tools.
Ensured the description aligns with the protocol's purpose and design without repeating information from other sections.
Improved Flow and Readability:
Organized content into clear sections for better readability and alignment with protocol requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study employs a quasi-experimental interventional model designed to evaluate the impact of gamified virtual reality sports exercises on mental health and life expectancy in elderly individuals (aged 60 and over) experiencing suicidal thoughts. Participants will be randomly assigned to either the experimental group, which will engage in VR-based sports training sessions utilizing gamification elements, or the control group, which will participate in conventional sports exercises without immersive technology or gamification. The intervention aims to enhance physical activity engagement through an interactive and supportive environment, fostering community and social interaction among participants. Data will be gathered through baseline assessments and follow-up evaluations to gauge changes in mental health indicators, including suicidal ideation and perceived life expectancy.
| Arm | Type | Receives |
|---|---|---|
| Gamified Virtual Reality Sports Exercise Program for Elderly Individuals with Suicidal Thoughts | Experimental | Behavioral: Traditional Sports Exercise Program for Elderly Individuals with Suicidal ThoughtsParticipants will engage in a gamified virtual reality (VR) sports exercise program specifically designed for elderly individuals experiencing suicidal thoughts. The intervention consists of structured, immersive VR sessions that incorporate various sports activities tailored to accommodate the physical abilities of the participants. These sessions will utilize gamification elements, including points, rewards, and friendly competition, to enhance motivation and engagement. Participants will join weekly VR exercise sessions guided by trained facilitators who will provide support and encouragement throughout the program. The aim is to foster social interaction among participants, creating a sense of community and reducing feelings of loneliness. Each session will last approximately 60 minutes and will include warm-up exercises, the main VR activity, and a cooldown |
| Active Comparator: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thought | Experimental | Behavioral: Gamified Virtual Reality Sports Exercise ProgramParticipants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement. The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected. Behavioral: Traditional Sports Exercise Program Structured physical activity sessions led by experienced facilitators. Low-impact sports and exercises tailored for older adults. |
Who may qualify
- Ages
- 58 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly men aged 60 years and older
- Suicidal thoughts confirmed by psychological evaluation
- Symptoms of depression and loneliness
- Informed consent provided by participant or family
- Residency in Tehran, Iran
Key exclusion criteria (5 listed)
- Severe cognitive impairment or dementia
- Current therapeutic interventions for suicidal ideation or mental health issues
- Acute medical conditions requiring immediate attention
- History of severe substance abuse or dependence
- Significant physical disabilities preventing basic physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Virtual Reality Sports Exercise ProgramAlso: VR-Based Gamified Exercise Program, Immersive VR Sports Training for Elderly, Virtual Reality Gamification for Mental HealthParticipants in the experimental group will participate in a variety of sports exercises designed in a virtual reality environment utilizing gamification elements to enhance engagement. The intervention will include: * Structured virtual reality sports sessions guided by specially trained facilitators. * Use of gamified features such as rewards, points, and friendly competition to stimulate motivation. * Incorporation of social elements where participants can interact with each other during sessions to foster community and support. | Behavioural | Active Comparator: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thought |
| Traditional Sports Exercise Program for Elderly Individuals with Suicidal ThoughtsAlso: Conventional Physical Activity Program, Low-Impact Sports for Elderly, Group-Based Exercise for Mental Healthparticipants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement. The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected. | Behavioural | Gamified Virtual Reality Sports Exercise Program for Elderly Individuals with Suicidal Thoughts |
Primary outcome
Change in Suicidal Ideation as Measured by the Beck Scale for Suicide Ideation (BSSI)
Time frame: Baseline and post-intervention (2 months).
Description: The Beck Scale for Suicide Ideation (BSSI) is a validated 21-item questionnaire used to assess the intensity and frequency of suicidal thoughts. Scores range from 0 to 38, with higher scores indicating greater severity of suicidal ideation. This measure will be administered at baseline and after 2 months of participation to evaluate changes in suicidal ideation among elderly participants.
Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and post-intervention (2 months).
Description: The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item questionnaire used to assess the severity of depressive symptoms based on DSM-5 criteria. Scores range from 0 to 27, with higher scores indicating more severe depression. This measure will be administered at baseline and after 2 months of participation to evaluate changes in depressive symptoms among elderly participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- BackgroundChambers, L.W. and L.W. Chambers, Prevalence and monetary costs of dementia in Canada. 2016: Miscellaneous Agency.
- Individual participant dataSharing planned: No. Due to persistent technical difficulties in providing a functional web address for the IPD sharing plan on the clinical trial site, interested parties are encouraged to contact zin368@gmail.com for further information. We have encountered issues that prevent the proper display or access of the sharing link, necessitating this alternative means of communication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zinat Dr Zinat Ebrahimi, Professor principal investigator
Islamic Azad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Virtual Reality Sports Exercise Program and Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts in people with Suicidal Ideation and Depression, run by Islamic Azad University, Sanandaj at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation as Measured by the Beck Scale for Suicide Ideation (BSSI) (time frame: Baseline and post-intervention (2 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.