Anxiety DisordersprevANSNCT05682365
Online Personalized Intervention for the Prevention of Anxiety.
A study testing prevANS intervention in people with Anxiety Disorders, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- prevANS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GAD-7 <10 at baseline
- GAD-7 ≥10 at baseline and a negative diagnosis of anxiety disorders by CIDI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Facultad de Psicología y Logopedia
Málaga, 29010
Patricia Moreno-Peral, Dr, 637710461, predictmalaga@hotmail.com
Patricia Moreno-Peral, Dr
About this study
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.
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.
- Conditions
- Anxiety Disorders
- Being tested
- prevANS intervention
- Keywords
- Anxiety Disorders, Primary prevention, Randomized controlled trial, m-Health, e-Health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevANS interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| prevANS intervention | Experimental | In this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA). Receives: Behavioral: prevANS intervention |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (16)
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).
Measured: 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).
Measured: 12 months
Probability of anxiety measured by the Spanish predictA risk algorithm
The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders
Measured: 12 months
Probability of depression measured by the Spanish predictD risk algorithm
The Spanish predictD risk algorithm measures 13 risk factors for depression
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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)
Measured: 12 months
Subgroup analysis according to sex
A subgroup analysis will be conducted according to sex of the participants (women or men)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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%
Measured: 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%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start30 Jan 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Estatal de Investigación (AEI), Institute of Health Carlos III (ISCIII), Biomedical Research Institute of Málaga, European Regional Development Fund
- Responsible party
- Principal investigator, Patricia Moreno Peral, University of Malaga
- Investigators
- Patricia Moreno-Peral, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682365
- Sponsor's protocol ID
- PID2020-119652RA-I00
- Acronym
- prevANS
- Status last verified
- Nov 2023
- First submitted
- 8 Dec 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38023964
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05682365
- Acronym / sponsor ID
- prevANS / PID2020-119652RA-I00
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety Disorders, Primary prevention, Randomized controlled trial, m-Health, e-Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Agencia Estatal de Investigación (AEI), Institute of Health Carlos III (ISCIII), Biomedical Research Institute of Málaga, European Regional Development Fund
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prevANS intervention | Experimental | Behavioral: prevANS interventionIn this arm, participants will receive an online personalized intervention to prevent anxiety disorders based on a risk predictive algorithm (predictA). |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GAD-7 <10 at baseline
- GAD-7 ≥10 at baseline and a negative diagnosis of anxiety disorders by CIDI
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevANS interventionprevANS 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). | Behavioural | prevANS intervention |
Primary outcome
Primary Outcome Measure
Time frame: 12 months
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.
16 secondary outcomes
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
Time frame: 12 months
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months
Probability of anxiety measured by the Spanish predictA risk algorithm
Time frame: 12 months
Probability of depression measured by the Spanish predictD risk algorithm
Time frame: 12 months
Quality of life measured by SF-12
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Cost-utility
Time frame: 12 months
Acceptability and satisfaction with the intervention (prevANS intervention) measured by u-MARS scale
Time frame: 12 months
Mediator of the intervention: cognitive change
Time frame: 12 months
Subgroup analysis according to age
Time frame: 12 months
Subgroup analysis according to sex
Time frame: 12 months
Subgroup analysis according to education level
Time frame: 12 months
Subgroup analysis according to anxiety symptoms at baseline (through the GAD-7 questionnaire)
Time frame: 12 months
Subgroup analysis according to depressive symptoms at baseline (through the PHQ-9 questionnaire)
Time frame: 12 months
Subgroup analysis according to risk level of anxiety (through the predictA risk algorithm)
Time frame: 12 months
Subgroup analysis according to risk level of depression (through the predictD risk algorithm)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 38023964Moreno-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Moreno-Peral, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prevANS intervention in people with Anxiety Disorders, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Moreno-Peral, PhD (+34951030534, predictmalaga@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.