Anxiety DepressionPeerMentorAnxDNCT07472894
AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN YOUTH
A study testing Peer-mentoring behavioral intervention and Health Education in people with Anxiety Depression, run by University of Patras at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial will be to evaluate the efficacy of an AI-informed peer-mentoring program to improve stress management and social skills and reduce the risk of depressive and anxiety symptoms in healthy adolescents (12-18 years old) and young adults (18-25 years old). Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Peer-mentoring behavioral intervention and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Healthy individuals aged 12-25 yrs old -
Exclusion Criteria: Chronic mental health conditions, severe cognitive or communication deficits
-
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Greece1 site
University Hospital of Patras
Pátrai
Vaios Peritogiannis, PhD, 00306942023234, vperitogiannis@gmail.com
Italy1 site
Modena Health Authority
Modena
Luca Arcangeli, M.A., 00393290740000, pm@innovate.clust-er.it
About this study
Official title: PEER MENTORING FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN ADOLESCENTS AND YOUNG ADULTS
The goal of this clinical trial will be to evaluate the efficacy of an AI-informed peer-mentoring program to improve stress management and social skills and reduce the risk of depressive and anxiety symptoms in healthy adolescents (12-18 years old) and young adults (18-25 years old). The main question it aims to answer is whether the peer-mentoring behavioral intervention will achieve the desired behavioral changes and reduce the emergence of anxiety and depression symptoms. Researchers will compare the AI-informed peer-mentoring behavioral intervention program with a standard peer-mentoring program and a standard health educational program. Some study participants will be trained to be peer mentors and subsequently they will be paired with slightly younger mentees and they will attend shared activities for an academic year
Read the detailed description
Adolescence and young adulthood (12-25 years) represent critical developmental periods during which lifestyle patterns related to nutrition, physical activity, sleep, digital media use, social interaction, and stress regulation are consolidated and often persist into adulthood. Preventive interventions targeting these stages therefore offer substantial potential for long-term reduction of non-communicable disease (NCD) burden.
Although young people are often perceived as generally healthy, epidemiological evidence indicates a growing burden of NCD-related conditions in this population. More specifically, in terms of mental health conditions, anxiety and depressive disorders have risen sharply during the last decades, with depression rates among young people increasing by approximately 50% since 1990, contributing to impaired quality of life and increased risk of comorbid physical health problems. A substantial body of evidence links anxiety and depression risk to modifiable lifestyle and psychosocial behaviours established early in life, and behavioural interventions addressing these factors have demonstrated promising effects in young populations. However, existing interventions often show wide variability in design and outcomes and face persistent challenges related to long-term adherence, scalability, and equitable access. Many rely on professional-led delivery models requiring substantial human and financial resources, limiting their sustainability and reach, particularly in low-resource or geographically remote settings.
Digital health interventions have emerged as a promising means to improve accessibility and engagement while supporting self-monitoring and feedback. Digital approaches have demonstrated positive effects on behaviours related to physical activity, diet, sleep and stress management. Nevertheless, many digital interventions remain largely individualised and screen-centric, insufficiently leveraging the social environments in which young people's behaviours are embedded, which may limit sustained engagement and long-term behaviour change.
In this context, peer mentoring represents a promising, yet, underutilised approach for strengthening behavioural self-management and primary NCD prevention among adolescents and young adults. Peer mentoring involves structured, supportive relationships in which individuals with shared or similar lived experiences provide guidance, encouragement, and role modelling. During adolescence and young adulthood, peers exert a strong influence on attitudes, norms, motivation, and behaviour. Peer-led approaches are often perceived as more relatable, credible, and emotionally safe than authority- or expert-led interventions, fostering trust, social connectedness, and intrinsic motivation. Peer mentoring programmes have demonstrated effectiveness in promoting healthy behaviours and psychosocial outcomes in youth, particularly in school-based and community settings.
Peer mentoring aligns closely with contemporary self-management models by promoting active participation, shared responsibility, and empowerment rather than passive receipt of advice. In the context of NCD prevention, it can support the adoption and maintenance of health-promoting behaviours by embedding behaviour change within everyday social interactions and reinforcing positive social norms. Importantly, peer mentoring complements professional care, extending the reach and sustainability of preventive interventions.
In this context, the present clinical trial aims to evaluate the efficacy of a behavioral intervention program to prevent the development of anxiety and depressive disorders in young people aged 12-25 by promoting sustained health-protective behaviours through structured peer mentoring, supported by non-invasive digital technologies and AI-enabled personalisation . The intervention focuses on improving stress management and enhancing social competence and engagement thus proactively empowering young people to self-manage behavioural risk factors before they evolve into long-term health conditions. The AI-informed peer-mentoring intervention will be compared to standard peer mentoring and health educational intervention.
- Conditions
- Anxiety Depression
- Being tested
- Peer-mentoring behavioral intervention, Health Education
- Keywords
- Anxiety, Depression, Primary prevention, Peer-mentoring, Behavioral Intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-mentoring behavioral interventionBehavioural
The intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence.
Health EducationOther
Health education sessions delivered by professionals focusing on stress management and social skills
| Study group | Role | What they receive |
|---|---|---|
| AI-informed peer-mentoring behavioral intervention | Experimental | A structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring and supported by AI-informed tools, focusing on stress management and social competence. The intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence. Receives: Behavioral: Peer-mentoring behavioral intervention |
| Standard peer-mentoring behavioral intervention | Active comparator | A structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring but without AI-support Receives: Behavioral: Peer-mentoring behavioral intervention |
| Health educational intervention | Active comparator | Regular health education sessions delivered by professionals Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
Assessment of stress levels
Measured: From enrollment to the end of the intervention at 6 months
Revised Children Anxiety and Depression Scale (RCADS-25)
Assessment of anxiety and depressive symptoms in adolescents
Measured: From enrollment to intervention completion at 6 months
Depression Anxiety Stress Scale (DASS-21)
Assessment of anxiety, depressive and stress symptoms in young adults
Measured: From enrollment to study completion at 6 months
Depression Anxiety Stress Scale Youth (DASS-Y)
Assessment of anxiety, depressive and stress symptoms in adolescents
Measured: From enrollment to study completion at 6 months
KIDSCREEN-27 Social functioning sub-scale
Assessment of social functioning
Measured: From enrollment to study completion at 6 months
SF36 Social functioning sub-scale
Assessment of social functioning
Measured: From enrollment to study completion at 6 months
Secondary outcomes (7)
KIDSCREEN-27
Assessment of quality of life in adolescents
Measured: From enrollment to intervention completion at 6 months
Salivary cortisol levels
Assessment of HPA activity
Measured: From enrollment to intervention completion at 6 months
Screen-time self-reported questionnaire
Assessment of screen-time
Measured: From enrollment to intervention completion at 6 months
Pittsburgh Sleep Quality Index AYA version
Assessment of sleep quality
Measured: From enrollment to intervention completion at 6 months
Screen-time mobile tracking device
Assessment of screen-time
Measured: From enrollment to study completion at 6 months
Sleep actigraphic data
Assessment of sleep parameters with the use of an accelerometer
Measured: From enrollment to study completion at 6 months
Five Facet Mindfulness Questionnaire Short Form
It measures the 5 facets of mindfulness
Measured: From study enrollment to study completion at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- Modena Health Authority, University of Bologna, 6th Hellenic Health District
- Responsible party
- Principal investigator, Aikaterini Karaivazoglou, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472894
- Sponsor's protocol ID
- PMMH070326
- Acronym
- PeerMentorAnxD
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be anonymized and will be entered in databases available to researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEER MENTORING FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN ADOLESCENTS AND YOUNG ADULTS
- ClinicalTrials.gov ID
- NCT07472894
- Acronym / sponsor ID
- PeerMentorAnxD / PMMH070326
- Conditions
- Anxiety Depression
- Keywords
- Anxiety, Depression, Primary prevention, Peer-mentoring, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Collaborators
- Modena Health Authority, University of Bologna, 6th Hellenic Health District
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Mar 2026 (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.
The goal of this clinical trial will be to evaluate the efficacy of an AI-informed peer-mentoring program to improve stress management and social skills and reduce the risk of depressive and anxiety symptoms in healthy adolescents (12-18 years old) and young adults (18-25 years old). The main question it aims to answer is whether the peer-mentoring behavioral intervention will achieve the desired behavioral changes and reduce the emergence of anxiety and depression symptoms. Researchers will compare the AI-informed peer-mentoring behavioral intervention program with a standard peer-mentoring program and a standard health educational program. Some study participants will be trained to be peer mentors and subsequently they will be paired with slightly younger mentees and they will attend shared activities for an academic year
Detailed description
Adolescence and young adulthood (12-25 years) represent critical developmental periods during which lifestyle patterns related to nutrition, physical activity, sleep, digital media use, social interaction, and stress regulation are consolidated and often persist into adulthood. Preventive interventions targeting these stages therefore offer substantial potential for long-term reduction of non-communicable disease (NCD) burden.
Although young people are often perceived as generally healthy, epidemiological evidence indicates a growing burden of NCD-related conditions in this population. More specifically, in terms of mental health conditions, anxiety and depressive disorders have risen sharply during the last decades, with depression rates among young people increasing by approximately 50% since 1990, contributing to impaired quality of life and increased risk of comorbid physical health problems. A substantial body of evidence links anxiety and depression risk to modifiable lifestyle and psychosocial behaviours established early in life, and behavioural interventions addressing these factors have demonstrated promising effects in young populations. However, existing interventions often show wide variability in design and outcomes and face persistent challenges related to long-term adherence, scalability, and equitable access. Many rely on professional-led delivery models requiring substantial human and financial resources, limiting their sustainability and reach, particularly in low-resource or geographically remote settings.
Digital health interventions have emerged as a promising means to improve accessibility and engagement while supporting self-monitoring and feedback. Digital approaches have demonstrated positive effects on behaviours related to physical activity, diet, sleep and stress management. Nevertheless, many digital interventions remain largely individualised and screen-centric, insufficiently leveraging the social environments in which young people's behaviours are embedded, which may limit sustained engagement and long-term behaviour change.
In this context, peer mentoring represents a promising, yet, underutilised approach for strengthening behavioural self-management and primary NCD prevention among adolescents and young adults. Peer mentoring involves structured, supportive relationships in which individuals with shared or similar lived experiences provide guidance, encouragement, and role modelling. During adolescence and young adulthood, peers exert a strong influence on attitudes, norms, motivation, and behaviour. Peer-led approaches are often perceived as more relatable, credible, and emotionally safe than authority- or expert-led interventions, fostering trust, social connectedness, and intrinsic motivation. Peer mentoring programmes have demonstrated effectiveness in promoting healthy behaviours and psychosocial outcomes in youth, particularly in school-based and community settings.
Peer mentoring aligns closely with contemporary self-management models by promoting active participation, shared responsibility, and empowerment rather than passive receipt of advice. In the context of NCD prevention, it can support the adoption and maintenance of health-promoting behaviours by embedding behaviour change within everyday social interactions and reinforcing positive social norms. Importantly, peer mentoring complements professional care, extending the reach and sustainability of preventive interventions.
In this context, the present clinical trial aims to evaluate the efficacy of a behavioral intervention program to prevent the development of anxiety and depressive disorders in young people aged 12-25 by promoting sustained health-protective behaviours through structured peer mentoring, supported by non-invasive digital technologies and AI-enabled personalisation . The intervention focuses on improving stress management and enhancing social competence and engagement thus proactively empowering young people to self-manage behavioural risk factors before they evolve into long-term health conditions. The AI-informed peer-mentoring intervention will be compared to standard peer mentoring and health educational intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-informed peer-mentoring behavioral intervention | Experimental | Behavioral: Peer-mentoring behavioral interventionA structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring and supported by AI-informed tools, focusing on stress management and social competence. The intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence. |
| Standard peer-mentoring behavioral intervention | Active comparator | Behavioral: Peer-mentoring behavioral interventionA structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring but without AI-support |
| Health educational intervention | Active comparator | Other: Health EducationRegular health education sessions delivered by professionals |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Peer-mentoring behavioral interventionThe intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence. | Behavioural | AI-informed peer-mentoring behavioral intervention, Standard peer-mentoring behavioral intervention |
| Health EducationHealth education sessions delivered by professionals focusing on stress management and social skills | Other | Health educational intervention |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: From enrollment to the end of the intervention at 6 months
Assessment of stress levels
Revised Children Anxiety and Depression Scale (RCADS-25)
Time frame: From enrollment to intervention completion at 6 months
Assessment of anxiety and depressive symptoms in adolescents
Depression Anxiety Stress Scale (DASS-21)
Time frame: From enrollment to study completion at 6 months
Assessment of anxiety, depressive and stress symptoms in young adults
Depression Anxiety Stress Scale Youth (DASS-Y)
Time frame: From enrollment to study completion at 6 months
Assessment of anxiety, depressive and stress symptoms in adolescents
KIDSCREEN-27 Social functioning sub-scale
Time frame: From enrollment to study completion at 6 months
Assessment of social functioning
SF36 Social functioning sub-scale
Time frame: From enrollment to study completion at 6 months
Assessment of social functioning
7 secondary outcomes
KIDSCREEN-27
Time frame: From enrollment to intervention completion at 6 months
Salivary cortisol levels
Time frame: From enrollment to intervention completion at 6 months
Screen-time self-reported questionnaire
Time frame: From enrollment to intervention completion at 6 months
Pittsburgh Sleep Quality Index AYA version
Time frame: From enrollment to intervention completion at 6 months
Screen-time mobile tracking device
Time frame: From enrollment to study completion at 6 months
Sleep actigraphic data
Time frame: From enrollment to study completion at 6 months
Five Facet Mindfulness Questionnaire Short Form
Time frame: From study enrollment to study completion at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD will be anonymized and will be entered in databases available to researchers
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-mentoring behavioral intervention and Health Education in people with Anxiety Depression, run by University of Patras at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aikaterini Karaivazoglou, PhD (00306977711259, karaivaz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: From enrollment to the end of the intervention at 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.