RESUMO
Background: To 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. Methods: A 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. Discussion: To 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 registration: ClinicalTrials.gov: NCT05682365.
RESUMO
BACKGROUND: The different incidence rates of, and risk factors for, depression in different countries argue for the need to have a specific risk algorithm for each country or a supranational risk algorithm. We aimed to develop and validate a predictD-Spain risk algorithm (PSRA) for the onset of major depression and to compare the performance of the PSRA with the predictD-Europe risk algorithm (PERA) in Spanish primary care. METHOD: A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multi-level logistic regression and inverse probability weighting to build the PSRA. In Spain (4574), Chile (2133) and another five European countries (5184), 11 891 non-depressed adult primary care attendees formed our at-risk population. The main outcome was DSM-IV major depression (CIDI). RESULTS: Six variables were patient characteristics or past events (sex, age, sex×age interaction, education, physical child abuse, and lifetime depression) and six were current status [Short Form 12 (SF-12) physical score, SF-12 mental score, dissatisfaction with unpaid work, number of serious problems in very close persons, dissatisfaction with living together at home, and taking medication for stress, anxiety or depression]. The C-index of the PSRA was 0.82 [95% confidence interval (CI) 0.79-0.84]. The Integrated Discrimination Improvement (IDI) was 0.0558 [standard error (s.e.)=0.0071, Zexp=7.88, p<0.0001] mainly due to the increase in sensitivity. Both the IDI and calibration plots showed that the PSRA functioned better than the PERA in Spain. CONCLUSIONS: The PSRA included new variables and afforded an improved performance over the PERA for predicting the onset of major depression in Spain. However, the PERA is still the best option in other European countries.