AzTrials
AzTrials

Global Mental HealthReconnectedTRINCT07697807

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

An observational study of Global Mental Health, run by Fondation FondaMental.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Global Mental Health
What is being tested?
Moodbuster mobile application
How many people
256 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 1 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study 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).

Who may be able to join

  • 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.
  • Resources: Must have access to a smartphone with an internet connection for the duration of participation in the study.

Who cannot join

  • 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).
  • Mental Health treatment: Self-report screen:
  • "Do you currently receive psychological treatment for a mental disorder?" "Have you started taking prescribed medication for psychological or psychiatric problems (e.g., anxiety, depression, sleep problems) within the past four weeks?" (yes/no)
  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: A Full Factorial Randomized Trial Assessing the Incremental Effects of Personalized Micro-interventions and Social Prescribing on Mental Health of Vulnerable Populations - Individuals in Socio-economically Disadvantaged Conditions (France) Participating in a Multicenter 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.

Read the detailed description

Europe is experiencing a period of rapid transformation, driven by digitalisation, changing demographics due to urbanisation, ageing, and migration, as well as global developments such as climate change and geopolitical instability (European Commission, 2023). While developments bring new opportunities, such as greater global connectivity and increased flexibility in work and education, they also introduce cognitive and emotional challenges. These challenges include, amongst others, identity struggles, shaped by factors such as migration and social media, and information overload and social disconnection due to urbanisation and digitalisation. Research has shown that not all citizens adapt equally well to these changes. It is suggested that vulnerable citizens in Europe, such as people with low socioeconomic status, immigrants, youth, and elderly, are affected the most by global societal developments. Hence, putting vulnerable citizens at higher risk for lower mental wellbeing.

Increasing mental wellbeing in vulnerable citizens:

Psychosocial interventions are a viable way to empower individuals to gain more control over their life, learn how to adapt to stressful events and promote mental health and wellbeing (World Health Organization, 2021). They often extend beyond a sole focus on individual behaviours, incorporating a broader range of social and environmental interventions (World Health Organization, 2021). This multilevel perspective aligns with the RECONNECTED project that adopts a complex system perspective on mental health and wellbeing that takes into account risk and protective factors at different levels of description: societal challenges (meta), living environment (macro), social factors (meso), and individual factors (micro) . To maximise mental health benefits, it is suggested that interventions need to address various risk and protective factors across multiple levels (e.g., meso and micro). In the RECONNECTED project, we offer a digital psychosocial intervention with culturally adapted and personalised intervention tools to various vulnerable populations in Europe. This is a multicomponent intervention that targets mental health literacy, social connectedness, and psychological resilience.

et pour la description : Europe is experiencing a period of rapid transformation, driven by digitalisation, changing demographics due to urbanisation, ageing, and migration, as well as global developments such as climate change and geopolitical instability (European Commission, 2023). While developments bring new opportunities, such as greater global connectivity and increased flexibility in work and education, they also introduce cognitive and emotional challenges (Molua, 2024; Romanello et al., 2021). These challenges include, amongst others, identity struggles, shaped by factors such as migration and social media, and information overload and social disconnection due to urbanisation and digitalisation (Saiphoo \& Vahedi, 2019). Research has shown that not all citizens adapt equally well to these changes. It is suggested that vulnerable citizens in Europe, such as people with low socioeconomic status, immigrants, youth, and elderly, are affected the most by global societal developments (Benevolenza \& DeRigne, 2019; Molua, 2024; Vasilescu et al., 2020). Hence, putting vulnerable citizens at higher risk for lower mental wellbeing (Benevolenza \& DeRigne, 2019; Molua, 2024; Vasilescu et al., 2020).

Increasing mental wellbeing in vulnerable citizens Psychosocial interventions are a viable way to empower individuals to gain more control over their life, learn how to adapt to stressful events and promote mental health and wellbeing (World Health Organization, 2021). They often extend beyond a sole focus on individual behaviours, incorporating a broader range of social and environmental interventions (World Health Organization, 2021). This multilevel perspective aligns with the RECONNECTED project that adopts a complex system perspective (Mitchell, 2009) on mental health and wellbeing that takes into account risk and protective factors at different levels of description: societal challenges (meta), living environment (macro), social factors (meso), and individual factors (micro). To maximise mental health benefits, it is suggested that interventions need to address various risk and protective factors across multiple levels (e.g., meso and micro). In the RECONNECTED project, we offer a digital psychosocial intervention with culturally adapted and personalised intervention tools to various vulnerable populations in Europe. This is a multicomponent intervention that targets mental health literacy, social connectedness, and psychological resilience.

Mental health literacy is a core component of most psychosocial interventions. It aims to increase knowledge and understanding about mental health and illness and how to get support if needed (Jorm, 2015; Jorm et al., 1997) and has demonstrated the ability to increase mental health awareness, reduce stigma, and change attitudes towards mental health and mental health seeking behaviours (Brijnath et al., 2016). Research has shown that vulnerable populations, such as individuals with lower income and educational levels, tend to have lower mental health literacy compared to those with higher socioeconomic status (Soria-Martínez et al., 2024), which is important considering that low mental health literacy is one of the primary reasons for the treatment gap between those who need help and those who seek help (Tambling et al., 2023).

Social connection, social support, and a sense of belonging are fundamental human needs (Baumeister \& Leary, 1995; Wickramaratne et al., 2022). Strong social networks foster belonging and act as protective factors for mental well-being by providing support and resources, enhancing self-worth, and broadening perspectives (Keim-Klärner et al., 2023; Steinhoff \& Reiner, 2024). Social isolation, on the other hand, is associated with increased risks of anxiety, depression, and other psychological distress (Baumeister et al., 2007; Rutenfrans-Stupar et al., 2019; Wickramaratne et al., 2022). Therefore, social connectedness is particularly crucial for overall wellbeing (Rutenfrans-Stupar et al., 2019) especially when people experience high level of stress and uncertainty.

Resilience is commonly defined as the capacity to adapt to and recover from adversity. A theoretical approach to understand resilience, is the 'metatheory of resilience and resiliency' (MRR) (Richardson, 2002), which aligns well with the RECONNECTED conceptual framework. MRR emphasizes the dynamic interaction between individuals and their environment in managing and recovering from adverse life events. Resilience is thus not simply an individual trait (micro) but is influenced by external factors, such as social support (meso) and access to resources (macro) (Hall et al., 2023; Liu et al., 2017; Patel et al., 2017). Being a vulnerable citizen has been found to be associated with decreased resilience, making them more susceptible to the negative effects of adversities (Siriwardhana et al., 2014). By fostering resilience, individuals can develop greater emotional adaptability and coping mechanisms to navigate stressors more effectively (Siriwardhana et al., 2014). One way to enhance resilience could be through micro-interventions. Micro-interventions target specific social and psychological processes and alter the way that people think, feel, or behave in their daily lives (Fuller-Tyszkiewicz et al., 2019). Micro-interventions conceptually differ from standard and brief interventions in their scope, objectives, and time frame (Baumel et al., 2020; Elefant et al., 2017). They are narrower in focus, with a clear and targeted goal, and a timely approach, reducing the effort needed for completion. Unlike traditional interventions that often target broad clinical outcomes (e.g., reducing social anxiety), micro-interventions are designed to address more immediate and situational challenges, such as reducing stress before an exam or overcoming hesitation to attend a social event (Baumel et al., 2020). While their initial focus is to generate short-term positive effects, they contribute incrementally to longer-term goals like enhancing overall well-being (Fuller-Tyszkiewicz et al., 2019). In addition, micro-interventions offer greater scalability by being low-cost and overcoming common barriers to access, such as time constraints and scheduling difficulties (Lee et al., 2025).

Digital solutions:

Existing interventions psychosocial interventions do not always reach those in need due to limited cultural adaptation, language barriers, as well as lack of personalisation. These challenges are further reinforced by stigma, low mental health literacy and the high costs of interventions, which particularly affect socially disadvantaged groups (Dobalian \& Rivers, 2008; Jorm, 2012). Digital interventions present a promising solution to bridge this gap by empowering individuals' self-management and enhancing scalability, affordability, accessibility, and safety of interventions (Aschentrup et al., 2024; Muñoz, 2010; Stark et al., 2022). Furthermore, empirical evidence supports the efficacy, effectiveness, and acceptability of digital health promotion and prevention tools (Muñoz, 2010). Moreover, evidence has shown that mental health literacy interventions, social activation, and micro-interventions can also be delivered digitally effectively. For instance, a meta-analysis of digital mental health literacy interventions reported large effect sizes for improving literacy and medium effect sizes for mental health outcomes, comparable to face-to-face interventions (Yeo et al., 2024). Similarly, digital interventions focusing on increasing social connectedness offer enhanced usability by enabling on-demand access and consolidating activity information in one platform, making it more user-friendly than traditional pen-and-paper methods (Lee et al., 2023; Patel et al., 2021). Moreover, digital delivery of micro-interventions provides unique advantages, such as automatic monitoring, notifications, and integrated messaging tools, which are not feasible in offline formats (Baumel et al., 2020) To realize the potential of digital interventions, they need to be tailored to the specific needs and cultural context of the target population. Cultural adaptation means alignment of interventions with the cultural context of the target population. This may include language adjustments and the use of culturally meaningful metaphors, such as symbols and sayings (Bernal et al., 1995; Nagayama et al., 2016). Personalisation, on the other hand, means adjustment of intervention with the individual's (current) needs and characteristics. This means that, based on these factors, a specific intervention may or may not be offered (Cohen et al., 2021). Persuasive technologies, such as machine learning algorithms, can support personalization by predicting an individual's psychological state and informing decisions about whether, when, and which intervention to offer (Abd-Alrazaq et al., 2023; Baumel et al., 2020; Ciharova et al., 2024; Moshe et al., 2021).

Being tested
Moodbuster mobile application
Keywords
Resiliance, Social activation, Literacy, Global Mental Health
Medical subject headings
Literacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moodbuster mobile applicationOther

    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.

Study groups in NCT07697807
Study groupRoleWhat they receive
Mental Health LiteracyControl group receiving only the literacy module intervention
Receives: Other: Moodbuster mobile application
Literacy and social activationGroup receiving social activation module in addition to literacy module
Receives: Other: Moodbuster mobile application
Literacy and personalized microinterventionGroup receiving personalized microintervention module in addition to literacy module
Receives: Other: Moodbuster mobile application
Literacy, social activation and personalized microinterventionGroup receiving all modules
Receives: Other: Moodbuster mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (3)
  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697807
Sponsor's protocol ID
2026-A00629-42
Acronym
ReconnectedTRI
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Global Mental Health, run by Fondation FondaMental.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Haddad (+33(0)1.49.81.34.46, recherche@fondation-fondamental.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health Continuum - Short Form (MHC-SF) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in