Background Serious game-interactive digital cognitive behavioural therapy (dCBT) has emerged as an innovative approach to managing depression, combining the efficacy of CBT with gamified and interactive elements to enhance user engagement and adherence. This protocol outlines the structure and methodology of a randomised controlled trial (RCT) designed to evaluate the effectiveness of serious game-interactive dCBT in alleviating depressive symptoms, compared to psychoeducation. Methods This study is a parallel-group superiority RCT to assess the efficacy of the serious game-interactive dCBT. In total, 124 patients aged 18 to 45 years with mild to moderate major depression were recruited primarily from the community, with a smaller portion from the outpatient department of Beijing Anding Hospital, and were included in two groups. Randomisation was performed using computer-generated random allocation sequences concealed within sealed envelopes. The intervention duration is 6 weeks. Assessments, conducted using a combination of self-rated and observer-rated scales, are scheduled at baseline, week 2, week 4, and week 6. The primary outcome is improvement in depressive symptoms at week 6, measured by the reduction in Beck Depression Inventory (BDI) scores. Secondary outcomes assessed at week 6 include changes in automatic thoughts, pleasure responsiveness, and quality of life. Self-rated outcomes are collected every 2 weeks to investigate the process of change. As the revision was submitted, participant recruitment has been completed. Discussion This is the first RCT of serious game-interactive dCBT conducted in China. The interactive design overcomes the limitations of computerised CBT, while the fully digital traceability model addresses the issue of CBT treatment adherence. Additionally, the modular architecture facilitates the scalability of applications. Given its accessibility and cost-effectiveness, serious game-interactive dCBT may pave new pathways for depression treatment. Trial registration ChiCTR2400085819.
Yang et al. (Fri,) studied this question.