Online Personalized Intervention for the Prevention of Anxiety. (prevANS)

Effectiveness of an Online Personalized Intervention Based on a Risk Algorithm for the Universal Prevention of Anxiety: Randomized Controlled Trial. The prevANS Study.

Agencia Estatal de Investigación (AEI), Institute of Health Carlos III (ISCIII), Institute of Biomedical Research in Málaga (IBIMA), European Regional Development Fund (FEDER)

Objective: 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: Randomized controlled trial, with two parallel arms and 12 months follow-up. The entire process of recruitment, randomization, intervention and follow-up will be carried out from a web platform designed for the study (web prevANS). Through a communication campaign, where announcements and informative videos will be produced, and through the dissemination on prevANS website, 2,000 Spanish and Portuguese adult participants without anxiety in the baseline of the study will be recruited. The participants will be randomly assigned to the prevANS intervention, which will be self-guided and can be implemented from the prevANS web or from the participants' Smartphone (through an APP), or to a control group. The prevANS intervention will have different intensities depending on the risk level of the population, evaluated from the already validated risk algorithm for anxiety: predictA. Participants with a low risk of anxiety will receive information on their level and profile (risk factors) of anxiety and psychoeducational information periodically. Participants with moderate and high risk of anxiety will also receive information on their risk level and profile, but will also include a cognitive-behavioral training (problem solving, decision-making, handling thoughts / concerns and emotions and communicational skills). Both groups of risk will work towards manage stressors and enhance protective factors. The control group will not receive any intervention, but they will fill out the same questionnaires as in the intervention group. The main result will be the incidence of new cases of anxiety disorders measured by CIDI, and the secondary results will be the reduction of anxiety (GAD-7) and depression (PHQ-9) symptoms, of the risk probability of anxiety and depression (predictA and predictD algorithms) and improvement of quality of life measured by SF-12 and EuroQol, and cost-effectiveness and cost-utility.

In this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA).

In this arm, participants will continue receiving the usual care from their health providers. However, they will not receive any intervention, but they will fill out the same questionnaires as in the intervention group.

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 already validated risk algorithm for anxiety: predictA. Participants will be classified as moderate-high or low risk of anxiety. Both groups of risk will receive information on their level and profile (risk factors) of anxiety and psychoeducational information periodically; also, they will work towards manage stressors and enhance protective factors. However, participants with moderate-high risk of anxiety will also receive a cognitive-behavioral training (problem solving, decision-making, handling thoughts / concerns and emotions and communicational skills).

Rate of anxiety disorders measured by the Composite International Diagnostic Interview (CIDI). CIDI is a structured diagnostic interview that provides current diagnoses of anxiety disorders according to DSM.

The General Anxiety Questionnaire (GAD-7) measures generalized anxiety disorder through 7 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of anxiety, the scale range is 0 to 21 (7 items).

The Patient Health Questionnaire-9 (PHQ-9) measures symptoms of depression through 9 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of depression, the scalen range is 0 to 27 (9 items).

The 12-item Short Form (SF-12) measures quality of life related to physical health and quality of life related to mental health. Scores on the scales range from 0 to 100. Higher scores are equivalent to better health-related quality of life.

It will be conducted from two perspectives: (1) a societal perspective and (2) a National Health System perspective. We will calculate incremental cost-effectiveness ratio (ICER) using the incremental cost (difference in costs between arms) divided by incremental effectiveness (difference in the number of diagnoses of anxiety disorders between arms).

It will be conducted from two perspectives: (1) a societal perspective and (2) a National Health System perspective. We will calculate incremental cost-effectiveness ratio (ICER) using the incremental cost (difference in costs between arms) divided by incremental QALYs (difference in QALYs between arms). Quality-adjusted life years (QALYs) will be measured using the EuroQol five questionnaire (EuroQol-5D).

The User Version of the Mobile Application Rating Scale (u-MARS) consists of 23 items assessing app quality, each of which is scored 1 ('poor') to 5('excellent'), except items 14-17 and item 19, which also include the "not applicable" option. Higher scores are equivalent to higher app quality.

The cognitive change will be evaluated through the number of negative thoughts worked and modified in the app

A subgroup analysis will be conducted according to age of the participants (from 18 to 30 years; from 31 to 50 years; and > 50 years)

A subgroup analysis will be conducted according to education level of the participants (without primary education; primary education; secondary education; or higher education)

The General Anxiety Questionnaire (GAD-7) measures generalized anxiety disorder through 7 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of anxiety, the scale range is 0 to 21 (7 items). The subgroups will be: 1) from 0 to 5 points; and 2) > 5 points

The Patient Health Questionnaire-9 (PHQ-9) measures symptoms of depression through 9 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of depression, the scalen range is 0 to 27 (9 items). The subgroups will be: 1) from 0 to 5 points; 2) from 6 to 10 points; and 3) > 10 points

The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders. The subgroups will be: 1) probability of risk from 0 to 6%; and 2) probability of risk >6%

The Spanish predictD risk algorithm measures 13 risk factors for depression. The subgroups will be: 1) probability of risk from 0 to 9%; and 2) probability of risk >9%

Inclusion Criteria: GAD-7 <10 at baseline Exclusion Criteria: Not have a smartphone and internet for personal use Unable to speak Spanish Documented terminal illness Documented cognitive impairment Documented serious mental illness (psychosis, bipolar, addictions, etc.) Being involved in any psychological intervention or treatment

The data generated during this study will include detailed information on the protocols and analyses used to allow their reproducibility and future analyses by other groups. The data generated from this research will be made available to affiliated investigators through secure and anonymized databases. Only investigators with specific independent ethics committee approval will have access to any anonymized data. The research coordinator of the prevANS study can be contacted for de-identified data requests. Consent for such data sharing will be integral to enrollment in the study, and our participants will be asked about their willingness to have their data shared to advance health research.