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Improving Mental Health in Vulnerable Populations Through Micro-Interventions and Social Prescribing: A Factorial Randomized Trial

NCT07697807 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2026-07-13

No results posted yet for this study

Summary

This full factorial trial is part of the RECONNECTED project (www.reconnected-project.eu). RECONNECTED involves a consortium of 11 European partners responding to global societal developments affecting mental wellbeing of vulnerable citizens. The project will offer a digital support system with culturally adapted and personalised intervention tools to various vulnerable populations that are understudied and difficult to reach with regular mental health interventions (i.e. youth, people with low SES, migrant populations, and older adults). The digital support system targets both individual and social factors simultaneously (i.e. mental health literacy, psychological resilience and social connectedness) to maximise health benefits. The main aim of this trial is to examine if personalised micro-interventions and social activation add wellbeing benefits to mental health literacy. The additional effects of personalised micro-interventions and social activation to mental health literacy will be tested through nine full factorial trials in nine European countries. The second objective is to evaluate whether integrating a machine learning algorithm into personalised micro-interventions improves the effectiveness of the personalised micro-interventions compared to the standard version. This analysis will be conducted using pooled data from the nine trial sites. The third objective is to conduct a process evaluation to assess the feasibility of the digital support system, including usability, perceived usefulness, overall satisfaction, potential unintended negative effects, and engagement.

Conditions

  • Global Mental Health

Interventions

OTHER

Moodbuster mobile application

The digital support system is a new model of community care that addresses both individual and social level factors (i.e., mental health literacy, social connectedness, and psychological resilience) to maximise health benefits. The specific content of the digital support system is adapted to suit various vulnerable communities (e.g., youth, elderly, migrants, and people with low SES). All participants will start with the mandatory mental health literacy module, which includes a brief onboarding to the digital support system. After completion of this module, the app opens access to the other two components, social activation and personalized micro-interventions. Participants are free to use the interventions however works best for them, but it is designed to be used for approximately 6 weeks. The app can be accessed on a computer and smartphone, however, the micro-interventions are smartphone based.

Sponsors & Collaborators

  • Fondation FondaMental

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-04-01
Completion
2027-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07697807 on ClinicalTrials.gov