About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mental well-being status: Classified on the MHC-SF as either "Languishing" or "Moderately Mentally Healthy."
Age: Must be 18 years of age or older.
Location: Resident of disadvantaged areas within the Val-de-Marne department, defined for this study as municipalities with the highest percentage of households living below the poverty line (more than 20% of households, according to INSEE data).
Skills: Must demonstrate a sufficient level of linguistic and cognitive understanding to communicate with the research team and complete the pre-screening process.
Disqualifiers
Severe mental illness: Self-report screen: "Do you currently have any of the following mental disorders diagnosed by a psychologist, psychiatrist, or other mental health professional?" (checklist includes schizophrenia, bipolar, psychosis, severe depression with hospitalisation).
Inability to commit to engagement: Self-report screen: "Are you able and willing to use the digital tool weekly for the next 6 weeks and complete 4 surveys?"
Insufficient language comprehension: Basic comprehension check. Part of (electronic or in-person) consent procedure: prospect can read and understand the study information.
Trial population
Resident of disadvantaged areas within the Val-de-Marne department, defined for this study as municipalities with the highest percentage of households living below the poverty line (more than 20% of households, according to INSEE data).
Trial design
Other
Prospective
Treatments tested in this trial
Moodbuster mobile application
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Mental Health Continuum - Short Form (MHC-SF)
The primary outcome is the change in the total score on the Mental Health Continuum - Short Form (MHC-SF) (Keyes, 2002) between baseline (T0) and the 6-week assessment (T1), compared between the control group and the intervention groups. The study parameter is a continuous score corresponding to the sum of the 14 questionnaire items (total score ranging from 0 to 70), with higher scores indicating better mental wellbeing. The intervention will be considered effective if the change in MHC-SF scores over time differs significantly between the intervention groups and the control group, with greater improvement observed in the intervention groups, as estimated using a linear mixed-effects model.
Secondary outcomes
Mental Health Literacy
Mental Health Literacy is measured with the Mental Health Literacy Questionnaire - Short Version for Adults (MHLq-SVa) (Campos et al., 2022) . The MHLq-SVa is based upon the validated MHLq-ya, originally designed for young adults (Campos et al., 2016) . This self-report tool assesses four key aspects of mental health literacy: Knowledge of mental health problems, erroneous beliefs/stereotypes, first-aid skills and help seeking behaviour, and self-help strategies (Campos et al., 2022) . Participants respond to 16 statements, rating their agreement on a five-point Likert scale, ranging from 1 ('strongly disagree') to 5 ('strongly agree'). Psychometric and validation analyses across American, Portuguese, and East-Asian populations, confirmed the scale's strong psychometric properties and adaptability for cross-cultural applications.
Resilience
The Connor-Davidson Resilience Scale - Brief Version (CD-RISC-10) is assessed to measure resilience. The CD-RISC-10 consists of 10 selected items from the original CD-RISC (Campbell-Sills et al., 2009; Connor \& Davidson, 2003) and evaluating an individual's ability to cope with and thrive despite adversity during the past month. Responses are rated on a five-point Likert scale, ranging from 0 ('not true at all') to 4 ('true nearly all the time'). This scale has demonstrated strong psychometric properties when assessing trait resilience across European community samples (Notario-Pacheco et al., 2011; Wollny \& Jacobs, 2023) . The French version of the CD-RISC-10 was validated by Chaudieu et al.
Social connexion
The UCLA-9 Loneliness Scale is used to measure loneliness (Luhmann et al., 2016) . The UCLA-9 is a shortened version of the revised 20-item UCLA Loneliness Scale (Russell et al., 1980) . The nine items are rated on a 4-point Likert scale, ranging from 1 ('never') to 4 ('always'). Total scores range from 9 to 36, with higher scores indicated higher levels of loneliness. The UCLA-9 captures three dimensions of loneliness: intimate connectedness, relational connectedness, and collective connectedness. The validity and reliability of the UCLA-9 is comparable with those of the (revised) 20-item version (Bo et al., 2025; Liu et al., 2025) , and works reliably well across different ages (Panayiotou et al., 2023)
Locations
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