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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Depression
• Intervention / Treatment: Behavioral: Peer-mentoring behavioral intervention; Other: Health Education

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 Type: Interventional
• Enrollment (Estimated): 1680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aikaterini Karaivazoglou, PhD; Phone Number: 00306977711259; Email: karaivaz@hotmail.com

Study Locations

• Greece
  • Pátrai, Greece
    • University Hospital of Patras
    • Contact: Vaios Peritogiannis, PhD; Phone Number: 00306942023234; Email: vperitogiannis@gmail.com
• Italy
  • Modena, Italy
    • Modena Health Authority
    • Contact: Luca Arcangeli, M.A.; Phone Number: 00393290740000; Email: pm@innovate.clust-er.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-informed peer-mentoring behavioral intervention; 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.	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.
Active Comparator: Standard peer-mentoring behavioral intervention; A structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring but without AI-support	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.
Active Comparator: Health educational intervention; Regular health education sessions delivered by professionals	Other: Health Education; Health education sessions delivered by professionals focusing on stress management and social skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS-10)	Assessment of stress levels	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	From enrollment to intervention completion at 6 months
Depression Anxiety Stress Scale (DASS-21)	Assessment of anxiety, depressive and stress symptoms in young adults	From enrollment to study completion at 6 months
Depression Anxiety Stress Scale Youth (DASS-Y)	Assessment of anxiety, depressive and stress symptoms in adolescents	From enrollment to study completion at 6 months
KIDSCREEN-27 Social functioning sub-scale	Assessment of social functioning	From enrollment to study completion at 6 months
SF36 Social functioning sub-scale	Assessment of social functioning	From enrollment to study completion at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KIDSCREEN-27	Assessment of quality of life in adolescents	From enrollment to intervention completion at 6 months
Salivary cortisol levels	Assessment of HPA activity	From enrollment to intervention completion at 6 months
Screen-time self-reported questionnaire	Assessment of screen-time	From enrollment to intervention completion at 6 months
Pittsburgh Sleep Quality Index AYA version	Assessment of sleep quality	From enrollment to intervention completion at 6 months
Screen-time mobile tracking device	Assessment of screen-time	From enrollment to study completion at 6 months
Sleep actigraphic data	Assessment of sleep parameters with the use of an accelerometer	From enrollment to study completion at 6 months
Five Facet Mindfulness Questionnaire Short Form	It measures the 5 facets of mindfulness	From study enrollment to study completion at 12 months

Collaborators and Investigators

• Sponsor: University of Patras
• Collaborators: University of Bologna; Modena Health Authority; 6th Hellenic Health District

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Primary prevention; Behavioral Intervention; Peer-mentoring
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: PMMH070326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be anonymized and will be entered in databases available to researchers
• IPD Sharing Time Frame: After publication of study results
• IPD Sharing Access Criteria: Researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No