- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07697807
Improving Mental Health in Vulnerable Populations Through Micro-Interventions and Social Prescribing: A Factorial Randomized Trial (ReconnectedTRI)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michelle Haddad
- Número de teléfono: +33(0)1.49.81.34.46
- Correo electrónico: recherche@fondation-fondamental.org
Copia de seguridad de contactos de estudio
- Nombre: Andrei Szoke
- Correo electrónico: reconnected@fondation-fondamental.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Mental Health Literacy
Control group receiving only the literacy module intervention
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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.
|
|
Literacy and social activation
Group receiving social activation module in addition to literacy module
|
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.
|
|
Literacy and personalized microintervention
Group receiving personalized microintervention module in addition to literacy module
|
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.
|
|
Literacy, social activation and personalized microintervention
Group receiving all modules
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental Health Continuum - Short Form (MHC-SF)
Periodo de tiempo: 6 months
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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.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental Health Literacy
Periodo de tiempo: 6 months
|
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.
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6 months
|
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Resilience
Periodo de tiempo: 6 months
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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.
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6 months
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Social connexion
Periodo de tiempo: 6 months
|
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)
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6 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-A00629-42
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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