Study Protocol of a Pilot Trial Evaluating the Efficacy of an Integrated Therapeutic Intervention Based on Role-Playing Games (RPGs) in Youths with Anxiety, Depression and Emotional Dysregulation Disorders

Adolescence and early adulthood are critical developmental periods marked by an increasing vulnerability to emotional dysregulation and social difficulties, highlighting the need for engaging psychosocial interventions. This protocol presents a pilot study on the efficacy, feasibility, and acceptability of a structured group intervention based on Role-Playing Games (RPGs), designed to promote and support psychological well-being in transitional-aged youths. The study plans to recruit 54 participants (aged 15-24) who will take part in a 12 weekly, 2-hour RPG-based intervention facilitated by trained clinicians. These clinicians will guide patients through narrative role-playing and a guided mentalization-based therapy through the gaming experience. All participants will be assessed at pre-, mid- and post-intervention, as well as during the 1- and 6-month follow-up, in the following dimensions: a) mood; b) anxiety; c) emotional regulation; d) alexithymia; e) coping skills. The following assessment tools will be administered: Hospital Anxiety and Depression Scale (HADS), Difficulties in Emotion Regulation scale (DERS), Toronto Alexithymia Scale (TAS-20), Coping Orientation to Problems Experienced (Brief-COPE). We expect to demonstrate a good feasibility, a higher participant engagement and treatment adherence, and improvements in all emotional and affective dimensions. This study seeks to establish foundational data to inform larger randomized controlled trials, with a follow-up, positioning RPG-based group interventions as potentially accessible, engaging, and convenient tools within youth mental health services.