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

University of Malaga

Status: Enrolling

Conditions: Anxiety Disorders

Treatments: Behavioral: prevANS intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05682365

PID2020-119652RA-I00

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• GAD-7 <10 at baseline
• GAD-7 ≥10 at baseline and a negative diagnosis of anxiety disorders by CIDI

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,000 participants in 2 patient groups

prevANS intervention

Experimental group

Description:

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

Treatment:

Behavioral: prevANS intervention

Control group

No Intervention group

Description:

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.