Contemporary Clinical Trials Communications (Dec 2022)
Protocol for a randomised placebo-controlled trial investigating the efficacy and safety of a vitamin-mineral formula targeting dysregulated emotions in teenagers: The balancing emotions of adolescents with micronutrients (BEAM) study
Abstract
Background: Emotional dysregulation (ED) is a significant contributing factor to psychological distress in young people. ED is a transdiagnostic dimension characterized by an excessive reactivity to negative emotional stimuli with affective (anger) and behavioral (aggression) components, and is present across anxiety, mood and behavioral disorders. Due to early onset, high prevalence and persistence, ED in childhood is one of the most psychosocially impairing and cost-intensive mental health conditions, with not enough children improving with conventional treatments. Clinical trials have established preliminary efficacy of micronutrients (vitamins and minerals) in the treatment of ED. This project expands the research to examine micronutrient efficacy for teenagers with ED. Methods: This study is the first double-blind (participant and investigators) 8 week randomized controlled trial (with 8 week open-label extension and one year follow-up) designed to explore the efficacy and safety of micronutrients compared with placebo in 150 medication-free emotionally dysregulated youth (12–17 years), referred via self-referral, delivered remotely throughout New Zealand, using a website for monitoring symptoms, with a psychologist available online via text, email and video for assessment and monitoring. The primary outcome measures will be the Clinical Global Impression (CGI-I), the reactivity subscale of the Emotion Dysregulation Inventory (EDI) and the Clinician Rated Temper and Irritability Scale (CL-ARI). Discussion: Micronutrient intervention delivered alongside online assessment and monitoring has the potential to transform delivery of mental health care to young people who may not be willing or able to access traditional therapies. We also hope that this intervention shows acceptability across different ethnicities.
