Online Personalized Intervention for the Prevention of Anxiety.

Anxiety Disorders Clinical Trial

— prevANS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682365
• Other study ID #: PID2020-119652RA-I00
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of Malaga
• Contact: Patricia Moreno-Peral, PhD
• Phone: +34951030534
• Email: predictmalaga[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

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).

Locations

Country	Name	City	State
Spain	Facultad de Psicología y Logopedia	Málaga

Sponsors (5)

Lead Sponsor	Collaborator
University of Malaga	Agencia Estatal de Investigación (AEI), European Regional Development Fund (FEDER), Institute of Biomedical Research in Málaga (IBIMA), Institute of Health Carlos III (ISCIII)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Probability of anxiety measured by the Spanish predictA risk algorithm	The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders	12 months
Secondary	Probability of depression measured by the Spanish predictD risk algorithm	The Spanish predictD risk algorithm measures 13 risk factors for depression	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subgroup analysis according to sex	A subgroup analysis will be conducted according to sex of the participants (women or men)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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