Effectiveness of a universal personalized intervention for the prevention of anxiety disorders: Protocol of a randomized controlled trial (the prevANS project)

Abstract

BackgroundTo date, all preventive anxiety disorders interventions are one-fit-all and none of them are based on individual level and risk profile. The aim of this project is to design, develop and evaluate an online personalized intervention based on a risk algorithm for the universal prevention of anxiety disorders in the general population. MethodsA randomized controlled trial (RCT) with two parallel arms (prevANS vs usual care) and 1-year follow-up including 2000 participants without anxiety disorders from Spain and Portugal will be conducted.The prevANS intervention will be self-guided and can be implemented from the prevANS web or from the participants' Smartphone (through an App). The prevANS intervention will have different intensities depending on the risk level of the population, evaluated from the risk algorithm for anxiety: predictA. Both low and moderate-high risk participants will receive information on their level and profile (risk factors) of anxiety disorders, will have access to stress management tools and psychoeducational information periodically. In addition, participants with a moderate-high risk of anxiety disorders will also have access to cognitive-behavioral training (problem-solving, decision-making, communication skills, and working with thoughts). The control group will not receive any intervention, but they will fill out the same questionnaires as the intervention group.Assessments will be completed at baseline, 6 and 12-month follow-up. The primary outcome is the cumulative incidence of anxiety disorders. Secondary outcomes include depressive and anxiety symptoms, risk probability of anxiety disorders (predictA algorithm) and depression (predictD algorithm), improvement in physical and mental quality of life, and acceptability and satisfaction with the intervention. In addition, cost-effectiveness and cost-utility analyses will also be carried out from two perspectives, societal and health system, and analyses of mediators and moderators will also be performed. DiscussionTo the best of our knowledge, prevANS study will be the first to evaluate the effectiveness and cost-effectiveness of a personalized online intervention based on a risk predictive algorithm for the universal prevention of anxiety disorders. Trial registrationClinicalTrials.gov: NCT05682365.