NCT06856083

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 11, 2025

Last Update Submit

March 3, 2025

Conditions

Keywords

Gamified virtual reality exercisesElderly mental healthSuicidal thoughts interventionPhysical activity in older adultsVR sports trainingDepression reductionLife expectancy improvementQuasi-experimental studyNon-pharmacological interventionInteractive exercise programMental health support for seniorsGamification in healthcareElderly population studyCommunity engagement through exerciseInnovative health interventions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and post-intervention (2 months).

Study Arms (2)

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

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.

Behavioral: Gamified Virtual Reality Sports Exercise Program

Interventions

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.

Also known as: VR-Based Gamified Exercise Program, Immersive VR Sports Training for Elderly, Virtual Reality Gamification for Mental Health
Active Comparator: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thought

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.

Also known as: Conventional Physical Activity Program, Low-Impact Sports for Elderly, Group-Based Exercise for Mental Health
Gamified Virtual Reality Sports Exercise Program for Elderly Individuals with Suicidal Thoughts

Eligibility Criteria

Age58 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Science, Faculty of Humanities and Literature, Sanandaj Branch, Islamic Azad University, Sanandaj, Iran.

Sanandaj, Kurdistan Province, 6616947455, Iran

Location

Related Publications (1)

  • Chambers, L.W. and L.W. Chambers, Prevalence and monetary costs of dementia in Canada. 2016: Miscellaneous Agency.

    BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationDepression

Interventions

AgingMental Health

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological PhenomenaHealthPopulation Characteristics

Study Officials

  • Zinat Dr Zinat Ebrahimi, Professor

    Islamic Azad University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
In this study, participants will not be fully masked to group assignment due to the nature of the intervention. However, to mitigate bias in reporting and assessment, care providers who conduct the outcome assessments will be masked to the group assignments of the participants. This means that the assessors evaluating participants' mental health and life expectancy outcomes will not know whether individuals belong to the experimental group (engaging in VR-based sports exercises) or the control group (participating in traditional exercises). Additionally, researchers conducting the data analysis will also remain blinded to group allocations to ensure objective evaluation of results and reduce any potential biases during interpretation. This masking approach is designed to preserve the integrity of the study findings and ensure that the effects of the intervention are accurately attributed to the gamified VR sports exercises.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Physical Education and Sport Science

Study Record Dates

First Submitted

February 11, 2025

First Posted

March 4, 2025

Study Start

October 14, 2023

Primary Completion

November 25, 2024

Study Completion

December 20, 2024

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations