JMIR Publications

ABSTRACT

Background:

Serious games and digital cognitive training interventions are increasingly explored as scalable approaches to support individuals with major depressive disorder (MDD). However, many trials evaluating game-based interventions rely on weak comparators, making it difficult to distinguish intervention-specific effects from engagement or expectancy effects inherent to digital interventions.

Objective:

This study aimed to evaluate the feasibility and effectiveness of a fully remote serious game-based cognitive control training intervention for adults with MDD using a closely matched active control game.

Methods:

We conducted a fully remote, parallel-group, randomized controlled trial comparing a cognitive control-oriented videogame intervention (Legends of Hoa’manu) with a matched active control videogame. Adults with current MDD (N=57) were randomized to complete a 6-week home-based training program (30 sessions, 30 minutes each). Assessments were conducted at baseline, during training, post-intervention, and at 1-month follow-up. Co-primary outcomes were depressive symptoms measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) and cognitive control assessed using the Adaptive Cognitive Evaluation battery. Secondary outcomes included rumination, well-being, functional capacity, and engagement metrics.

Results:

Retention rates were high, with 81% (46/57) of participants completing post-intervention assessments and 77% (44/57) completing follow-up assessments. Participants in the experimental condition reported higher interest/enjoyment and effort during gameplay compared with the control condition. Depressive symptoms showed significant reductions from baseline to post-intervention across both intervention arms (P < .001, η²p = 0.49), and cognitive control scores improved modestly over time (P = .045; η²p = 0.09). No significant group × time interactions were observed for the primary outcomes, suggesting comparable improvements across conditions when using a closely matched active control game. Exploratory analyses indicated that, within the experimental group, higher perceived competence following the intervention was associated with greater reductions in depressive symptoms.

Conclusions:

These findings support the feasibility of scalable, home-based serious game interventions for depression. The lack of superiority over a closely matched control highlights the importance of rigorous comparator design in serious game trials and suggests that engagement-related mechanisms may contribute to clinical benefit. These findings highlight the need for future studies to examine moderators and mechanisms that could guide personalization of digital mental health interventions. Clinical Trial: Israeli Ministry of Health Clinical Trials Registry MOH_2021-07-20_005979.