Clinical trial NCT05682365: Online Personalized Intervention for the Prevention of Anxiety.
Official title: Effectiveness of an Online Personalized Intervention Based on a Risk Algorithm for the Universal Prevention of Anxiety: Randomized Controlled Trial. The prevANS Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety Disorders
Primary prevention
Randomized controlled trial
m-Health
e-Health
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Agencia Estatal de Investigación (AEI)
name: Institute of Health Carlos III (ISCIII)
name: Institute of Biomedical Research in Málaga (IBIMA)
name: European Regional Development Fund
First posted: 2023-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 12 months
Secondary outcomes:
measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
timeFrame: 12 months
measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: Probability of anxiety measured by the Spanish predictA risk algorithm
timeFrame: 12 months
measure: Probability of depression measured by the Spanish predictD risk algorithm
timeFrame: 12 months
measure: Quality of life measured by SF-12
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Cost-utility
timeFrame: 12 months
measure: Acceptability and satisfaction with the intervention (prevANS intervention) measured by u-MARS scale
timeFrame: 12 months
measure: Mediator of the intervention: cognitive change
timeFrame: 12 months
measure: Subgroup analysis according to age
timeFrame: 12 months
measure: Subgroup analysis according to sex
timeFrame: 12 months
measure: Subgroup analysis according to education level
timeFrame: 12 months
measure: Subgroup analysis according to anxiety symptoms at baseline (through the GAD-7 questionnaire)
timeFrame: 12 months
measure: Subgroup analysis according to depressive symptoms at baseline (through the PHQ-9 questionnaire)
timeFrame: 12 months
measure: Subgroup analysis according to risk level of anxiety (through the predictA risk algorithm)
timeFrame: 12 months
measure: Subgroup analysis according to risk level of depression (through the predictD risk algorithm)
timeFrame: 12 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Facultad de Psicología y Logopedia
Study officials:
affiliation: University of Malaga
name: Patricia Moreno-Peral, PhD
role: PRINCIPAL_INVESTIGATOR
References: