Online Personalized Intervention for the Prevention of Anxiety.

Summary

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.

Conditions

• Anxiety Disorders

Interventions

BEHAVIORAL

prevANS intervention

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).

Sponsors & Collaborators

• Agencia Estatal de Investigación (AEI)

  collaborator UNKNOWN

• Institute of Health Carlos III (ISCIII)

  collaborator UNKNOWN

• Institute of Biomedical Research in Málaga (IBIMA)

  collaborator UNKNOWN

• European Regional Development Fund

  collaborator OTHER

• University of Malaga

  lead OTHER

Principal Investigators

• Patricia Moreno-Peral, PhD · University of Malaga

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Spain

Study Locations