Menu
Not yet recruiting NCT07472894

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

No phase Interventional Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer-mentoring behavioral intervention, Health Education.
Who it may be relevant to
Registry conditions: Anxiety Depression. Basic parameters: 12 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Peer-mentoring behavioral intervention
    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.
  • Other Health Education
    Health education sessions delivered by professionals focusing on stress management and social skills

Primary outcome measures

  • Perceived Stress Scale (PSS-10) [Time frame: From enrollment to the end of the intervention at 6 months]
  • Revised Children Anxiety and Depression Scale (RCADS-25) [Time frame: From enrollment to intervention completion at 6 months]
  • Depression Anxiety Stress Scale (DASS-21) [Time frame: From enrollment to study completion at 6 months]
  • Depression Anxiety Stress Scale Youth (DASS-Y) [Time frame: From enrollment to study completion at 6 months]
  • KIDSCREEN-27 Social functioning sub-scale [Time frame: From enrollment to study completion at 6 months]
  • SF36 Social functioning sub-scale [Time frame: From enrollment to study completion at 6 months]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion Criteria: Healthy individuals aged 12-25 yrs old -

Exclusion Criteria: Chronic mental health conditions, severe cognitive or communication deficits

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Greece · 1 center
  • University Hospital of Patras — Pátrai
Italy · 1 center
  • Modena Health Authority — Modena

Identifiers

NCT: NCT07472894 · PMMH070326

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗