Examining the Effects of a Brief, Fully Self-Guided Mindfulness Ecological Momentary Intervention on Empathy and Theory-of-Mind for Generalized Anxiety Disorder: Randomized Controlled Trial

Background: The utility of brief mindfulness ecological momentary interventions (EMIs) to improve empathy and theory-of-mind has been underinvestigated, particularly in generalized anxiety disorder (GAD). Objective: In this randomized controlled trial, we aimed to examine the efficacy of a 14-day, fully self-guided, mindfulness EMI on the empathy and theory-of-mind domains for GAD. Methods: Adults (aged >= 18 y) diagnosed with GAD were randomized to a mindfulness EMI (68/110, 61.8%) or self-monitoring app (42/110, 38.2%) arm. They completed the Interpersonal Reactivity Index self-report empathy measure and theory-of-mind test (Bell-Lysaker Emotion Recognition Task) at prerandomization, postintervention, and 1-month follow-up (1MFU) time points. Hierarchical linear modeling was conducted with the intent-to-treat principle to determine prerandomization to postintervention (pre-post intervention) and prerandomization to 1MFU (pre-1MFU) changes, comparing the mindfulness EMI to self-monitoring. Results: Observed effects were generally stronger from pre-1MFU than from pre-post intervention time points. From pre-post intervention time points, the mindfulness EMI was more efficacious than the self-monitoring app on fantasy (the ability to imagine being in others' shoes; between-intervention effect size: Cohen d =0.26, P= .007; within-intervention effect size: Cohen d =0.22, P= .02 for the mindfulness EMI and Cohen d =-0.16, P= .10 for the self-monitoring app). From pre-1MFU time points, the mindfulness EMI, but not the self-monitoring app, improved theory-of-mind (a window into others' thoughts and intentions through abstract, propositional knowledge about their mental states, encompassing the ability to decipher social cues) and the fantasy , personal distress (stress when witnessing others' negative experiences), and perspective-taking (understanding others' perspective) empathy domains. The effect sizes were small to moderate (Cohen d =0.15-0.36; P <.001 to P =.01) for significant between-intervention effects from pre-1MFU time points. Furthermore, the within-intervention effect sizes for these significant outcomes were stronger for the mindfulness EMI (Cohen d =0.30-0.43; P <.001 to P =.03) than the self-monitoring app (Cohen d =-0.12 to 0.21; P= .001 to P >.99) from pre-1MFU time points. No between-intervention and within-intervention effects on empathic concern (feeling affection, compassion, and care when observing others in distress, primarily attending to their emotional well-being) were observed from pre-post intervention and pre-1MFU time points. Conclusions: The brief mindfulness EMI improved specific domains of empathy (eg, fantasy, personal distress, and perspective-taking) and theory-of-mind with small to moderate effect sizes in persons with GAD. Higher-intensity, self-guided or coach-facilitated, multicomponent mindfulness EMIs targeting the optimization of social relationships are likely necessary to improve the empathic concern domain in this population.