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.
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 6, 2023
November 1, 2023
1.6 years
December 8, 2022
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure
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.
12 months
Secondary Outcomes (16)
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
12 months
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
12 months
Probability of anxiety measured by the Spanish predictA risk algorithm
12 months
Probability of depression measured by the Spanish predictD risk algorithm
12 months
Quality of life measured by SF-12
12 months
- +11 more secondary outcomes
Study Arms (2)
prevANS intervention
EXPERIMENTALIn this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA).
Control group
NO INTERVENTIONIn 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- GAD-7 \<10 at baseline
- GAD-7 ≥10 at baseline and a negative diagnosis of anxiety disorders by CIDI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Malagalead
- Agencia Estatal de Investigación (AEI)collaborator
- Institute of Health Carlos III (ISCIII)collaborator
- Institute of Biomedical Research in Málaga (IBIMA)collaborator
- European Regional Development Fundcollaborator
Study Sites (1)
Facultad de Psicología y Logopedia
Málaga, 29010, Spain
Related Publications (1)
Moreno-Peral P, Rodriguez-Morejon A, Bellon JA, Garcia-Huercano C, Martinez-Vispo C, Campos-Paino H, Galan S, Reyes-Martin S, Sanchez Aguadero N, Rangel-Henriques M, Motrico E, Conejo-Ceron S. Effectiveness of a universal personalized intervention for the prevention of anxiety disorders: Protocol of a randomized controlled trial (the prevANS project). Internet Interv. 2023 Jun 22;34:100640. doi: 10.1016/j.invent.2023.100640. eCollection 2023 Dec.
PMID: 38023964DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Moreno-Peral, PhD
University of Malaga
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 8, 2022
First Posted
January 12, 2023
Study Start
January 30, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 6, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
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.