标题：Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial
摘要：Background
Prior evidence points towards lower cardiac vagal modulation in individuals with autism spectrum disorder (ASD) as compared to control groups. A cross-sectional phase in this study will gather more evidence concerning this topic. A longitudinal phase will explore the efficacy of a biofeedback intervention based on respiratory sinus arrhythmia (RSA) in adolescents with ASD. Finally, a feasibility study will focus on a non-supervised RSA biofeedback intervention in this population.
Methods
The cross-sectional phase includes the comparison of adolescents with ASD (
n=38) and age- and gender-matched typically developing peers. A standardized assessment will be used which contains physiological, cortisol, and behavioral measurements. The longitudinal phase contains a randomized, single-blinded, and sham-controlled design to determine the efficacy of supervised RSA biofeedback in adolescents with ASD (
n=128). A follow-up phase of 5 weeks is included to evaluate the presence of retention effects. During the latter, a feasibility study will focus on a non-supervised intervention (
n=64). Assessments as described previously are scheduled after the intervention and the follow-up phase.
Discussion
First, more conclusive evidence will be provided for the presence of lower cardiac vagal modulation in adolescents with ASD as well as the association between these lower values and physiological and behavioral indices. Second, the supervised intervention in adolescents with ASD is hypothesized to upregulate this cardiac vagal modulation and positively change behavioral and physiological parameters. Third, evidence regarding the feasibility and acceptability of a non-supervised intervention may open novel avenues for home-based interventions in this population.
Trial registration
ClinicalTrials.gov
NCT04628715. Registered on 13 November 2020.
Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-021-05709-4.
