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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 256
- 主要终点
- Mental Health Continuum - Short Form (MHC-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Literacy and social activation
Group receiving social activation module in addition to literacy module
干预措施: Moodbuster mobile application (Other)
Literacy and personalized microintervention
Group receiving personalized microintervention module in addition to literacy module
干预措施: Moodbuster mobile application (Other)
Literacy, social activation and personalized microintervention
Group receiving all modules
干预措施: Moodbuster mobile application (Other)
Mental Health Literacy
Control group receiving only the literacy module intervention
干预措施: Moodbuster mobile application (Other)
结局指标
主要结局
Mental Health Continuum - Short Form (MHC-SF)
时间窗: 6 months
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.
次要结局
- Mental Health Literacy(6 months)
- Resilience(6 months)
- Social connexion(6 months)