Mindfulness-based group therapy protocol aims to explore oxytocinergic system and empathy in schizophrenia

Schizophrenia (SCZ) is a severe mental disorder characterized by positive, negative, and cognitive symptoms, often leading to significant social and functional impairment. Current treatments primarily target positive symptoms, leaving substantial unmet needs for negative symptoms and social cognition deficits, including empathy. Mindfulness-based interventions (MBI) show promise for SCZ, and emerging research links MBI to changes in oxytocin (OXT) levels in healthy individuals. The oxytocinergic system is also implicated in social cognition and empathy. This study addresses the gap in understanding the interplay between mindfulness, empathy, and genetic factors within the oxytocinergic system in SCZ.

This is a protocol for a parallel-group, proof-of-concept randomized controlled trial (RCT) with N = 60 participants. Individuals with schizophrenia will be randomly assigned to either mindfulness-based group therapy (MBGT) alongside treatment as usual (TAU) or TAU alone. Participants in the MBGT arm will receive weekly MBGT sessions for a treatment period of four weeks. Baseline assessments (T0) will be followed by post-intervention assessments (T1) four weeks later. The study aims to estimate effect sizes for within- and between-group effects with corresponding confidence intervals.

As this is a protocol paper, the study has not yet generated results. However, the researchers outline several key objectives and expected insights. They aim to: > Explore the effect of mindfulness-based group therapy (MBGT) on oxytocin (OXT) levels and empathy in persons with schizophrenia (SCZ). The protocol also seeks to investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in SCZ patients. Furthermore, it will examine if PRS for empathy and specific genetic configurations in the oxytocin-receptor are associated with MBGT outcomes and OXT levels. The study will also track changes in positive and negative symptoms, depression, anxiety, social functioning, and mindfulness at both within-group and between-group levels across the MBGT+TAU and TAU conditions. This comprehensive approach aims to uncover potential biological mechanisms underlying mindfulness's effects in SCZ.