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.

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: prevANS intervention

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Moreno-Peral, PhD; Phone Number: +34951030534; Email: predictmalaga@hotmail.com
• Study Contact Backup: Name: Sonia Conejo-Cerón, PhD; Phone Number: +34951030534; Email: soniafundacionimabis@hotmail.com

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Recruiting
    • Facultad de Psicología y Logopedia
    • Contact: Patricia Moreno-Peral, Dr; Phone Number: 637710461; Email: predictmalaga@hotmail.com
    • Principal Investigator: Patricia Moreno-Peral, Dr
    • Sub-Investigator: Sonia Conejo-Cerón, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prevANS intervention; In this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA).	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).
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)	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).	12 months
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)	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).	12 months
Probability of anxiety measured by the Spanish predictA risk algorithm	The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders	12 months
Probability of depression measured by the Spanish predictD risk algorithm	The Spanish predictD risk algorithm measures 13 risk factors for depression	12 months
Quality of life measured by SF-12	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.	12 months
Cost-effectiveness	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).	12 months
Cost-utility	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).	12 months
Acceptability and satisfaction with the intervention (prevANS intervention) measured by u-MARS scale	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.	12 months
Mediator of the intervention: cognitive change	The cognitive change will be evaluated through the number of negative thoughts worked and modified in the app	12 months
Subgroup analysis according to age	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)	12 months
Subgroup analysis according to sex	A subgroup analysis will be conducted according to sex of the participants (women or men)	12 months
Subgroup analysis according to education level	A subgroup analysis will be conducted according to education level of the participants (without primary education; primary education; secondary education; or higher education)	12 months
Subgroup analysis according to anxiety symptoms at baseline (through the GAD-7 questionnaire)	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	12 months
Subgroup analysis according to depressive symptoms at baseline (through the PHQ-9 questionnaire)	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	12 months
Subgroup analysis according to risk level of anxiety (through the predictA risk algorithm)	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%	12 months
Subgroup analysis according to risk level of depression (through the predictD risk algorithm)	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%	12 months

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Agencia Estatal de Investigación (AEI); Institute of Health Carlos III (ISCIII); Institute of Biomedical Research in Málaga (IBIMA); European Regional Development Fund (FEDER)
• Investigators: Principal Investigator: Patricia Moreno-Peral, PhD, University of Malaga

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Primary prevention; m-Health; Anxiety Disorders; e-Health
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PID2020-119652RA-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No