Investigators will implement a quasi-experimental, two-arm repeated measures study to evaluate a workplace mental health program in two food manufacturing factories in Negeri Sembilan. One factory will receive the Worksite Mental Health Program (WMHP) plus routine workplace practices; the other will continue routine practices and receive a general mental health information pamphlet. Assignment of intervention status is at the factory level, and workers are nested within their respective factories. The team reported that this design is chosen because randomisation is often infeasible in operational production settings. Data collection is set at three timepoints: baseline (T0), one month post-intervention (T1), and three months post-intervention (T2).
The WMHP comprises three core components delivered over eight weeks: psychoeducation to improve mental health literacy, mindfulness-based practices to support emotional awareness and attention regulation, and relaxation activities including progressive muscle relaxation and breathing exercises. Trained members of the research team will deliver the program using standardised protocol and materials. The comparison group will not receive the structured program; instead, comparison-factory workers will be offered routine workplace practices and a printed pamphlet containing general mental health information.
Primary outcomes are self-reported psychological symptom severity for depression, anxiety, and stress, together with occupational burnout. The protocol specifies use of the DASS-21 to assess depression, anxiety and stress symptoms, and the OLBI to measure exhaustion and disengagement associated with burnout. Secondary outcomes include job satisfaction, absenteeism, presenteeism, and economic outcomes related to productivity. Assessments occur at T0, T1, and T2. The investigators noted that repeated measurements are intended to capture both immediate and short-term sustained effects of the intervention on psychological wellbeing and workplace productivity.
The study is grounded in established occupational models of job stress and health. Investigators described mental health outcomes as consequences of prolonged exposure to workplace psychosocial stressors, mediated through individual stress responses, coping capacity, and behavioural adaptations. The WMHP targets both individual coping resources and contextual organisational factors. The trial uses an Input–Process–Output (IPO) logic model to map program inputs (trained facilitators, materials, management support), processes (psychoeducation, mindfulness, relaxation), and outputs (reductions in stress, anxiety, depression, burnout; improved engagement, satisfaction, and productivity).
A cost–benefit analysis (CBA) is incorporated into the protocol to estimate economic impact. Investigators intend to quantify productivity-related gains derived from reductions in absenteeism and presenteeism and to present economic outcomes alongside clinical effectiveness. The protocol cites existing systematic reviews that report favourable economic outcomes from workplace mental health programs, but also notes variability in the strength and sustainability of those benefits and emphasizes the lack of integrated CBA evidence in industrial settings, particularly in middle-income countries.
Participants will be full-time Malaysian workers aged 18–60 employed at the participating factories for at least one year. No minimum educational qualification is required, but participants must be able to read Bahasa Melayu or English to provide informed consent and complete self-administered questionnaires. Workers currently under active psychiatric treatment, those with chronic illnesses that could independently influence mental health or work performance (for example, heart disease, chronic kidney disease, cancer), and pregnant workers are excluded. The two participating factories were to be selected from a compiled list of willing factories using simple random sampling.
Changes over time in outcomes will be analysed using Generalised Estimating Equations (GEE), allowing repeated measures modeling of within- and between-group differences. The protocol explicitly recognises that intervention status is aligned with factory; investigators reported that differences between groups may reflect both the WMHP effect and factory-specific characteristics. The study team also indicated that no datasets have yet been generated or analysed, and that all relevant data will be made available upon study completion.
The investigators acknowledged key limitations inherent to the design: only one intervention factory and one comparison factory are included, so factory-level differences may confound intervention effects. The protocol does not report randomisation at the individual level and therefore cannot fully exclude residual confounding by organisational characteristics. The source did not report specific sample size calculations, instructor-to-participant ratios, or detailed procedures for adherence monitoring; those operational details were not provided in the protocol text. Finally, the time horizon for economic evaluation beyond the three-month follow-up was not specified. These gaps constitute unresolved questions for the final trial report and for stakeholders considering scalability in similar industrial contexts.