Gamified Virtual Reality Exercise for Suicidal Ideation in Older Adults

This study is a two-arm, pretest-posttest randomized controlled trial (RCT) with a 30-day follow-up period, designed to examine the effects of a gamified virtual reality (VR)-based exercise intervention on suicidal ideation among community-dwelling older adults. The study is conducted in Tehran, Iran. Participants are randomized (1:1) to either (a) a gamified VR-based exercise intervention or (b) a conventional exercise control condition. Outcomes are assessed at three time points: baseline (pre-intervention), immediately after the intervention (post-test), and 30 days after the intervention (follow-up). Sex differences in intervention response are examined as a secondary objective.

Randomization and Allocation: Randomization is conducted using a concealed allocation procedure. Group assignments are generated in advance and placed into sequentially numbered, opaque, sealed envelopes. An independent researcher not involved in participant assessment or intervention delivery manages the allocation process to ensure allocation concealment and minimize selection bias. Stratified randomization by sex is applied to ensure balanced sex distribution across groups. Outcome assessment is conducted by an independent clinical psychologist blinded to group allocation. Participants are instructed not to disclose their assigned condition during assessments. The statistician/data analyst is also blinded to group identity; groups are coded (e.g., Group A/Group B) prior to analysis and unblinded only after the primary analyses are completed.

Participants and Eligibility: Community-dwelling older adults aged 60 years and above (both men and women) residing in Tehran, Iran, who exhibit suicidal ideation, are recruited through convenience sampling from elderly care centers following public announcements about the study. After eligibility screening and clinical assessment, eligible participants are enrolled. A total of 220 eligible participants are randomized (1:1) to the gamified VR-based exercise intervention (n = 110) or the conventional exercise control condition (n = 110).

Inclusion Criteria:

1. Male or female, aged 60 years or older.
2. Presence of suicidal ideation as indicated by elevated scores on the Beck Scale for Suicide Ideation (BSSI) and clinical confirmation by a licensed psychologist.
3. Medical clearance from a physician confirming the ability to safely participate in low-to-moderate intensity physical activity.
4. Ability to understand study procedures and provide informed consent.
5. Willingness to participate in a 5-week exercise program and attend follow-up assessments.

Exclusion Criteria:

1. Severe cognitive impairment or neurological disorders that could interfere with questionnaire completion or VR participation.
2. Diagnosed with acute psychiatric conditions requiring immediate intensive treatment (e.g., active psychosis or high suicide risk requiring hospitalization).
3. Uncontrolled cardiovascular, musculoskeletal, or other medical conditions contraindicating physical exercise.
4. Concurrently enrolled in structured psychological or exercise intervention programs that could confound study outcomes.
5. Withdrawal of consent at any stage of the study.

Primary Outcome Measure: Suicidal ideation is assessed using the Beck Scale for Suicide Ideation (BSSI), a widely validated instrument designed to measure the severity of suicidal thoughts, plans, and intent. The BSSI consists of 19 items, each rated on a 4-point scale ranging from 0 to 3. Total scores are calculated by summing item responses, yielding a possible score range from 0 to 57, with higher scores indicating greater severity of suicidal ideation. The total BSSI score is used in all statistical analyses. The BSSI is administered at baseline (pre-test), immediately after the intervention (post-test), and at the 30-day follow-up assessment. In addition to the self-report assessment, all participants are evaluated by a licensed clinical psychologist to confirm the presence of suicidal ideation prior to enrollment.

Secondary Objective - Sex Differences: Between-sex differences in BSSI change scores (baseline to post-intervention and baseline to follow-up) are examined. Sex is included as a between-subject factor in exploratory analyses to assess whether the intervention effect differs between men and women.

Intervention - Gamified VR-Based Exercise Group: Participants assigned to the experimental group engage in a structured, gamified virtual reality (VR)-based exercise program delivered over a 5-week period. Sessions are conducted under supervision and incorporate immersive VR environments designed to enhance physical engagement and motivational involvement in structured activity. The intervention consists of 15 sessions (three sessions per week), each lasting approximately 30-45 minutes. Participants use Meta Quest 3 VR headsets (512 GB version) to complete immersive, game-based exercise modules. Three distinct VR training modules are implemented to reduce monotony and sustain engagement. Gamification elements include performance-based feedback, progressive challenges, structured task goals, and individualized non-monetary incentives designed to promote sustained participation and engagement. Participants' performance scores are recorded across sessions to promote mastery experiences and gradual self-improvement. Friendly competitive elements are incorporated cautiously to enhance engagement while prioritizing psychological safety. Exercise intensity and task progression are carefully supervised to match participants' physical capacity and tolerance. All sessions are supervised by trained personnel, including a sport science specialist and a gamification expert, to ensure safety, appropriate task progression, adherence, and appropriate exercise intensity for older adults.

Control Group - Conventional Exercise: The control group participates in conventional physical exercise sessions of comparable duration and frequency (5 weeks; 3 sessions/week; 15 sessions) but without VR exposure. Sessions are conducted under supervision and are designed to be comparable in structure and social contact to the VR condition. This parallel-group design enables comparison of changes in suicidal ideation across pre-test, post-test, and follow-up assessments, while isolating the added effect of the immersive VR component.

Protocol Development: To design and implement the gamified sport-exercise program within a VR environment, the research team consulted three faculty members with expertise in sport science, gamification, and VR-based intervention design. This interdisciplinary collaboration ensured the scientific validity, safety, and feasibility of the intervention protocol. Prior to enrollment, all participants undergo medical screening and are required to obtain physician clearance confirming their ability to safely engage in moderate-intensity physical activity. At the outset of the study, an in-person orientation session is conducted with participants' families and caregivers to explain study procedures and encourage supportive involvement. This step is intended to enhance adherence, motivation, and sustained participation throughout the intervention period. Given the age-related characteristics of the participants and the psychological vulnerability associated with suicidal ideation, a licensed psychologist is present during questionnaire administration and periodically monitors participants' psychological well-being throughout the intervention.

Safety Monitoring and Adverse Event Procedures: Participant safety is monitored throughout all intervention sessions by trained research staff experienced in working with older adults and VR-based exercise programs. Prior to each session, participants are asked about any new health concerns, discomfort, or symptoms that might affect their ability to participate safely. During the intervention, participants are continuously observed for signs of fatigue, balance difficulties, dizziness, nausea, headache, visual discomfort, or other symptoms commonly associated with immersive VR exposure. Participants are instructed to immediately report any discomfort. If symptoms occur, the activity is paused and appropriate support is provided. Short rest periods, hydration, and seated recovery are available whenever needed. All VR sessions are conducted in a supervised exercise area cleared of obstacles, and each participant is assigned an individual movement space to minimize collision, loss of balance, or fall risk. Any adverse events or participant-reported symptoms are documented by research staff immediately following the session.

Withdrawal and Discontinuation Criteria: Participants are informed that they may withdraw at any time without penalty. Discontinuation criteria after randomization include: (a) occurrence of an adverse event or new medical condition rendering participation unsafe, (b) participant-initiated withdrawal, (c) inability to continue due to scheduling or personal reasons, or (d) failure to meet the predefined minimum participation threshold.

Statistical Analysis Plan: Analyses are performed using SPSS version 27, with statistical significance set at p < .05. Prior to conducting the primary analyses, normality of suicidal ideation scores (BSSI) is examined using the Kolmogorov-Smirnov test. Homogeneity of variances between the experimental and control groups is evaluated using Levene's test. The assumption of homogeneity of regression slopes is examined by testing the interaction between group membership and baseline BSSI scores. Analysis of Covariance (ANCOVA) is performed to compare post-intervention and follow-up suicidal ideation scores between groups while statistically controlling for baseline (pre-test) BSSI total scores. Baseline suicidal ideation (BSSI total score) is entered as a covariate to adjust for initial differences and to provide a more precise estimation of the intervention effect. Effect sizes are reported using partial eta squared (η²p) to quantify the magnitude of group differences. At each time point (pre-test, post-test, and follow-up), participants in both groups complete the BSSI. This repeated measurement design enables examination of both short-term and sustained changes in suicidal ideation over time. Sex differences are examined by including Sex as a between-subject factor in exploratory analyses (Group × Time × Sex interaction).