Study Protocol for a Randomized Double Blind, Placebo Controlled Trial Exploring the Effectiveness of a Micronutrient...

Background: Anxiety and depression are conferring an increasing burden on society. Although treatments exist for both conditions, side effects, and difficulties accessing treatment prevent many people from receiving adequate assistance. Nutritional approaches have demonstrated some success in treating anxiety and depression. We plan to investigate whether a micronutrient formula, Daily Essential Nutrients, improves symptoms of anxiety and depression compared to a placebo in a community recruited sample. Methods: This will be a randomized, double blind placebo controlled study (RCT). Two hundred adults will be assigned to either a placebo or micronutrient group (placebo or Daily Essential Nutrients (DEN)) in a 1:1 ratio. Baseline data will be collected for 2 weeks, followed by 10 weeks of placebo or micronutrient intervention. Psychometrics will be used to measure progress and participant safety will be monitored weekly. Results: The primary outcome measures will be total scores on three measures of symptom severity at 10 weeks. Linear mixed modelling will be used to measure between group differences and effect sizes will be calculated using pooled mean scores and standard deviations over the course of the trial. Conclusions: If effective, micronutrients could provide an alternative treatment, with fewer barriers and adverse events than currently available treatments.