Online Personalized Intervention for the Prevention of Anxiety.
NCT ID: NCT05682365
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2023-01-30
2024-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
No interventions assigned to this group
prevANS intervention
In this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* GAD-7 ≥10 at baseline and a negative diagnosis of anxiety disorders by CIDI
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Agencia Estatal de Investigación (AEI)
UNKNOWN
Institute of Health Carlos III (ISCIII)
UNKNOWN
Institute of Biomedical Research in Málaga (IBIMA)
UNKNOWN
European Regional Development Fund
OTHER
University of Malaga
OTHER
Responsible Party
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Patricia Moreno Peral
PhD
Principal Investigators
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Patricia Moreno-Peral, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaga
Locations
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Facultad de Psicología y Logopedia
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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Patricia Moreno-Peral, Dr
Role: primary
References
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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.
Other Identifiers
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PID2020-119652RA-I00
Identifier Type: -
Identifier Source: org_study_id