AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
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.

Aikaterini Karaivazoglou, PhD contact

00306977711259

karaivaz@hotmail.com

2 sites in 2 countries

Greece1 site
  • University Hospital of Patras

    Pátrai

    Vaios Peritogiannis, PhD, 00306942023234, vperitogiannis@gmail.com

Other trials in Greece

Italy1 site
  • Modena Health Authority

    Modena

    Luca Arcangeli, M.A., 00393290740000, pm@innovate.clust-er.it

Other trials in Italy

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.

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 groups in NCT07472894
Study groupRoleWhat they receive
AI-informed peer-mentoring behavioral interventionExperimentalA 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 interventionActive comparatorA 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 interventionActive comparatorRegular 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.

  1. Perceived Stress Scale (PSS-10)

    Assessment of stress levels

    Measured: From enrollment to the end of the intervention at 6 months

  2. 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

  3. 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

  4. 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

  5. KIDSCREEN-27 Social functioning sub-scale

    Assessment of social functioning

    Measured: From enrollment to study completion at 6 months

  6. SF36 Social functioning sub-scale

    Assessment of social functioning

    Measured: From enrollment to study completion at 6 months

Secondary outcomes (7)
  1. KIDSCREEN-27

    Assessment of quality of life in adolescents

    Measured: From enrollment to intervention completion at 6 months

  2. Salivary cortisol levels

    Assessment of HPA activity

    Measured: From enrollment to intervention completion at 6 months

  3. Screen-time self-reported questionnaire

    Assessment of screen-time

    Measured: From enrollment to intervention completion at 6 months

  4. Pittsburgh Sleep Quality Index AYA version

    Assessment of sleep quality

    Measured: From enrollment to intervention completion at 6 months

  5. Screen-time mobile tracking device

    Assessment of screen-time

    Measured: From enrollment to study completion at 6 months

  6. Sleep actigraphic data

    Assessment of sleep parameters with the use of an accelerometer

    Measured: From enrollment to study completion at 6 months

  7. 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.

  1. First posted16 Mar 2026
  2. Study start1 Sep 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in