Exploring the mechanistic link between the oxytocinergic system and mindfulness training in adults with heightened stress: Study protocol for a double-blind, randomized, placebo-controlled trial (MOX-MIND)

• DOI: 10.31219/osf.io/y9w2a_v1
• Publication Date: 2025-03-03T18:50:40Z
• Authors: Eimi van Weert; Kaat Alaerts; Katleen Van der G...; Edward Debbaut; Hendrik-Jan De Vuyst; Jean Steyaert

Background. Oxytocin administration is increasingly considered a novel therapeutic support option for alleviating psychological distress in stress-related neuropsychiatric conditions, including anxiety disorders and depression.However, oxytocin as stand-alone treatment may fail to consistently target the relevant central autonomic circuitry without complementary supportive context that similarly stimulates stress regulatory states behaviours.Recent findings suggest neurophysiological mechanisms underlying regulation induced by mindfulness-based intervention (MBI) programs rely on an activation of endogenous oxytocinergic system. Accordingly, combining with training program enhance efficacy compared each alone.Methods. A randomized, double-blind, placebo-controlled clinical trial will be conducted 120 adults heightened complaints, randomly assigned one following four arms (30 participants per arm): + Mindfulness-based (MBI); MBI Placebo; Oxytocin; Placebo (control group). The or placebo nasal spray administered times week morning before mindfulness session six weeks, followed six-week post-treatment follow-up session.Primary endpoints include self-reported behavioural measures stress, depression, anxiety. Secondary skills, quality life, sleep negative thinking. Exploratory (i) electroencephalography (EEG), electrocardiography (ECG), skin conductance, respiration, measured during rest, meditation, induction, recovery; (ii) intervention-induced changes biological samples, hormonal levels cortisol DNA methylation receptor gene (OXTR); (iii) reactivity daily assessed through experience sampling heart rate/sleep monitoring. All outcome at baseline (T0), immediately post-intervention (T1), (T2).Discussion. These could provide valuable insights into how interventions might regulation, particularly populations impaired function.