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NCT Number: NCT07472894

AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN YOUTH

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

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras, Pátrai, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy individuals aged 12-25 yrs old -

Exclusion criteria

Chronic mental health conditions, severe cognitive or communication deficits

-

Treatment and study plan

Peer-mentoring behavioral intervention

Behavioral

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 education

Other

Health education sessions delivered by professionals focusing on stress management and social skills

Primary outcomes

  1. Perceived Stress Scale (PSS-10)

    Time frame: From enrollment to the end of the intervention at 6 months

    Assessment of stress levels

  2. 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

  3. 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

  4. 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

  5. KIDSCREEN-27 Social functioning sub-scale

    Time frame: From enrollment to study completion at 6 months

    Assessment of social functioning

  6. SF36 Social functioning sub-scale

    Time frame: From enrollment to study completion at 6 months

    Assessment of social functioning

Secondary outcomes

  1. KIDSCREEN-27

    Time frame: From enrollment to intervention completion at 6 months

    Assessment of quality of life in adolescents

  2. Salivary cortisol levels

    Time frame: From enrollment to intervention completion at 6 months

    Assessment of HPA activity

  3. Screen-time self-reported questionnaire

    Time frame: From enrollment to intervention completion at 6 months

    Assessment of screen-time

  4. Pittsburgh Sleep Quality Index AYA version

    Time frame: From enrollment to intervention completion at 6 months

    Assessment of sleep quality

  5. Screen-time mobile tracking device

    Time frame: From enrollment to study completion at 6 months

    Assessment of screen-time

  6. Sleep actigraphic data

    Time frame: From enrollment to study completion at 6 months

    Assessment of sleep parameters with the use of an accelerometer

  7. Five Facet Mindfulness Questionnaire Short Form

    Time frame: From study enrollment to study completion at 12 months

    It measures the 5 facets of mindfulness

Study contacts

Contact information is provided by the study sponsor or research team.

Aikaterini Karaivazoglou, PhD

CONTACT

[email protected]

00306977711259

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Collaborators

  • 6th Hellenic Health District
  • Modena Health Authority
  • University of Bologna

Registry information

Official study title

PEER MENTORING FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN ADOLESCENTS AND YOUNG ADULTS

Acronym: PeerMentorAnxD

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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