The Edu:Social Health Care Project: Investigating the Effects of an Online Socio-emotional Dyad Intervention on Healthcare Students' Mental Health, Resilience, Social Competencies and Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Depression Anxiety Stress Scale (DASS-21)
研究概览
简要总结
In this Edu:Social Health Care project, a randomized controlled trial with a socio-emotional intervention and a waitlist control group will be conducted to evaluate the effects of a partner-based empathy-compassion Dyad mental training (EmCo) intervention on healthcare students with regard to the following primary outcome domains: 1) mental health, 2) resilience, 3) social cohesion and support, 4) social skills, 5) coping and emotion regulation, and 6) social behaviors.
One main goal is to examine the effects of such adapted 8-week EmCo Dyad intervention within the health care context, with a particular focus on strengthening students' mental health, resilience, social skills and behaviors, and social cohesion as well as fostering interprofessional attitudes by pairing every week study partners across different healthcare disciplines with each other for practicing their daily Dyads (e.g., nursing students will practice daily via app with medical students).
A further aim is to validate the novel Dyad Voice Assessment (DYVA) task, which explores the use of app-based voice recordings as indicators of students' emotional states during their daily partner-based Dyad practice. By combining students' self-reported practice-related emotions with partner-based evaluations, this approach aims to generate new and innovate, more objective markers of training-induced changes in emotional processing and regulation over time in a real-live applied setting.
The final aim is to investigate the cognitive and affective mechanisms and factors underlying observed changes in students' mental health, resilience, social cohesion, social skills and social behaviors, that may explain observed training-related effects in primary outcome domains. Based on previous research, we expect the socio-emotional EmCo Dyad training to activate evolutionary old care- and affiliation-based motivational systems that foster positive affect and motivation, acceptance, trust social capacities and behavioral tendencies. These processes should go along with reduction in loneliness, stress and other mental vulnerabilities (anxiety, depression, burn-out etc.) and foster social skills such as empathy, compassion as well as social cohesion and resilience.
详细描述
One-quarter to one-third of university students experience a common mental health disorder each year, with evidence indicating rising distress and declining well-being over time. Healthcare students appear particularly vulnerable, showing increasing levels of burnout associated with poorer academic engagement and impaired professional development. Mindfulness- and compassion-based interventions, as well as socio-emotional learning programs, have shown promise in improving mental health outcomes such as depression, anxiety, stress, and burnout, and in strengthening resilience among healthcare students.
In recent years, classic mindfulness-based interventions focusing on individual mental practices have been expanded to include partner-based social practices, known as Dyads, which particularly target social skills such as empathy, (self-)compassion, and social cohesion. However, despite growing research on student well-being, partner-based Dyadic interventions have not yet been systematically investigated in healthcare student populations. Available evidence suggests that Dyads may be more effective than solitary mindfulness practices in reducing loneliness and social stress, strengthening social connection and cohesion, and enhancing resilience and optimism. Moreover, findings indicate that dyadic social practices engage mechanisms that differ from those underlying traditional mindfulness-based interventions.
Empathy, (self-)compassion, and deep listening are core socio-emotional skills in healthcare, supporting effective communication and emotional understanding. However, empathy can lead to empathic distress when individuals are repeatedly exposed to others' suffering, whereas compassion is considered more protective, as it relies on altruistic and care-based motivational systems associated with positive affect and regulatory processes that buffer emotional overwhelm. Despite this distinction, empathy and compassion have not yet been systematically taught to healthcare students in an evidence-based manner. To address this gap, the Edu:Social Health Care project implements the empathy-compassion Dyad training program (EmCo), which trains students to distinguish between empathy and empathic listening and empathy regulation to avoid moving into empathic distress during the first four weeks, and (self)compassion and compassionate listening during the subsequent four weeks.
The EmCo program builds on the Affect Dyad developed in the ReSource project and the online Dyad coaching format implemented in the CovSocial project, both of which demonstrated the effectiveness of partner-based dyadic mental training in inducing brain plasticity, reducing stress, enhancing psychological resilience, and strengthening social cohesion across multiple indicators of biopsychosocial health. In contrast, to the ReSource and CovSocial projects, the present program, includes a novel empathy versus compassion listening component to it. Further, compared with earlier 10-week online Dyad programs, EmCo reduces the intervention duration to eight weeks, aligning with standard mindfulness-based interventions such as MBSR and MBCT and improving feasibility for implementation in healthcare and educational settings.
Accordingly, the study is implemented as a randomized controlled trial in a sample of healthcare students (target N = 360). A multimethod assessment strategy will be used, including self-report validated trait and state questionnaires, behavioral computer tasks delivered at home through webapp, and ecological momentary assessment (EMA) methods based on push-notifications by the app. These different assessments are capturing changes across mental health, resilience, social cohesion and support, social skills, coping and emotion regulation, and social behaviors (e.g., listening, attachment behaviors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
After pre-screening and randomized allocation to the two groups, participants and coordination staff need to be aware of which intervention arm (EmCo intervention group or WCG group) the participant belongs to in order to be able to group into appropriate coaching slots and onboarding I and II sessions prior to starting the actual 8-week online interventions with daily Dyad practice. Outcome assessors and investigators remain blinded to participant allocation for the duration of the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18- and 65-years old.
- •actively enrolled student at the PMU.
- •Proficient in German.
- •Informed consent.
- •No symptoms of psychiatric disease within the past two years.
- •Stable internet access and necessary technical equipment (computer or laptop or tablet, and mobile phone with internet access).
- •No regular contemplative practice (≤ 50 hours total within the past six months); healthy population, non-clinical population.
排除标准
- •Insufficient German proficiency.
- •Lack of stable internet access or required devices (computer or laptop or tablet, and mobile phone with internet access).
- •No informed consent.
- •Not actively enrolled at PMU.
- •Regular contemplative practice (> 50 hours in the past six months (e.g., dyad, mindfulness, compassion-based practices).
- •Current psychiatric diagnosis or therapy, or reaching screening cutoffs on:
- •Patient Health Questionnaire-9 (PHQ-9; Martin et al., 2006; Löwe et al., 2004; Cutoff ≥ 10),
- •Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2007; Spitzer et al., 2006; Cutoff ≥ 10),
- •Toronto Alexithymia Scale-20 (TAS-20; Bagby et al., 1994; Ritz & Kannapin, 2000; Cutoff ≥ 61)
- •Standardized Assessment of Personality - Abbreviated Scale (SAPAS; Moran et al., 2003; Söchtig et al., 2012, Cutoff ≥ 4).
- •Moreover, participants endorsing suicidality on the PHQ-9 will be excluded.
研究组 & 干预措施
Empathy- and compassion-based socio-emotional mental training (EmCo)
The socio-emotional intervention will consist of two 1.5h online onboarding I and II sessions and then 8 weeks of weekly 1.5-hour online coaching sessions with expert teachers as well as daily dyad practice with a partner over 8 weeks.
干预措施: Experimental: Empathy- and compassion-based socio-emotional mental training (EmCo) (Behavioral)
Waitlist Control Group (WCG)
Initially, participants in the waitlist control group will not receive the intervention and will be offered the EmCo training only after the intervention group has completed the EmCo training program.
干预措施: Waitlist Control Group (WCG) (Other)
结局指标
主要结局
Depression Anxiety Stress Scale (DASS-21)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring depression, anxiety, and stress (Henry \& Crawford, 2005; Nilges \& Essau, 2021). Higher scores indicate more depression, anxiety, and stress.
Maslach Burnout Inventory-Students Survey (MBI-SS)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring burnout (Gumz et al., 2013; Maslach \& Jackson, 1981). Higher scores indicate more burnout.
UCLA Loneliness Scale (UCLA)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring loneliness severity (Döring \& Bortz, 1993; Russell et al., 1980). Higher scores indicate more loneliness.
Connor Davidson Resilience Scale (CD-RISC)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring psychological resilience (Connor \& Davidson, 2003; Sarubin et al., 2015). Higher scores indicate more resilience.
Social closeness (IOS per profession)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring the felt closeness between persons or groups/communities using a visual representation (Aron et al., 1992; Kinnunen \& Windmann, 2013). Higher score indicates more social closeness.
Interprofessionalism Scale (IPAS-D)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale (Norris et al., 2015; Pedersen et al., 2020) measuring attitudes that relate to the Core Competencies for Interprofessional Collaborative Practice (IPEC Report, 2011). Higher scores indicate more positive attitudes toward collaborative practice.
Social Support Scale (F-SozU K-6)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring the subjective feeling of having support available (Kliem et al., 2015). Higher scores indicate greater perceived social support.
Socio-Affective Video Task (SoVT)
时间窗: Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)
This task assesses behavioral empathy and compassion using emotional video clips (Klimecki et al., 2014). Higher scores indicate more empathy or more compassion.
Sussex-Oxford Compassion Scale for Self and Others (SOCS)
时间窗: Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)
A scale measuring self-compassion (SOCS-S) and compassion for others (SOCS-O; Gu et al., 2020). Higher scores indicate more compassion.
Mentalization Scale (MENTS)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2).
A scale measuring the capacity of envisioning one's and others' behaviors with reference to the underlying mental states (Dimitrijević et al., 2018). Higher scores suggesting a more sophisticated capacity for mentalizing.
Prosodic Features of Vocalized Emotional Expressions
时间窗: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Acoustic assessment of prosodic speech features during participants' daily Dyad practice, analyzed using audEERING devAIce software. The following parameters will be assessed: pitch (Hz), loudness (unitless), speaking rate (syllables per second), and intonation (unitless).
Affect Dimensions of Vocalized Emotional Expressions
时间窗: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Assessment of continuous affective dimensions of vocalized emotional expressions during participants' daily Dyad practice using audEERING devAIce software. The following parameters will be assessed: arousal, valence, and dominance (each ranging from -1 to 1). Based on arousal-valence scores, the following affect quadrant values will be calculated: high-arousal-high-valence, low-arousal-high-valence, low-arousal-low-valence, and high-arousal-low-valence.
Affect Categories of Vocalized Emotional Expressions
时间窗: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Classification of vocalized emotional expressions into affect categories during participants' daily Dyad practice using audEERING devAIce software. The following categories will be assessed: angry, happy, and sad, expressed as unitless values ranging from 0 to 1 representing category likelihood.
Stress intensity
时间窗: Assessed using an EMA design with five push-notification measurements per day, distributed across five 3-hour intervals, on four days within a two-week period, at pre-test (Baseline) and after the 8-week intervention period (post-intervention).
Custom items based on the Stress Appraisal Measure (SAM; Delahaye et al., 2015; Peacock \& Wong, 1990) measuring stress intensity. Higher scores indicate more intense stress.
Coping strategies
时间窗: Assessed using an EMA design with five push-notification measurements per day, distributed across five 3-hour intervals, on four days within a two-week period, at pre-test (Baseline) and after the 8-week intervention period (post-intervention).
Custom items based on the Brief-COPE (Carver, 1997; Knoll et al., 2005) and Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001; Loch et al., 2011) measuring Coping Strategies (Acceptance, Positive Reinterpretation, Social Support, Rumination, Self-Blame, Distraction). Higher scores indicate a higher use of the specified coping strategies.
Active Empathic Listening Scale (AELS)
时间窗: Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)
A scale measuring active empathic listening (Bodie, 2011). Higher scores indicate more active empathic listening.
Attachment behavior (ASQ)
时间窗: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A self-report questionnaire measuring attachment-related behaviors in interpersonal relationships, including proximity seeking, avoidance, and security (Hexel, 2004). Higher scores indicate more pronounced attachment-related behaviors.
次要结局
- Positive Affect (Affect Grid) (explanatory mechanism)(Assessed weekly during the course of 8 weeks of intervention)
- Emotion Acceptance (EAQ) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Gratitude Questionnaire-6 (GQ-5-G) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Self-Kindness Scale (SCS-SF) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Positive Interpretation Bias (ERT) (explanatory mechanism)(Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2))
- Mentalizing (MENTS) Scale (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Short Loneliness Scale (SLS) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Perceived Stress (PSS-10) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Depression (PHQ-2) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Empathic Concern & Distress (IRI) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- Trust (KUSIV3) (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- In-group-Out-group bias (ERT) (explanatory mechanism)(Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2))
- Coping strategies (explanatory mechanism)(Assessed weekly during the course of 8 weeks)
- DPR-Affect (Affect Grid; explanatory mechanism)(Assessed for 8 weeks during intervention period, before the daily exercise)
- DPR-involvement (explanatory mechanism)(Assessed for 8 weeks during intervention period, only in the intervention group, after the daily exercise)
- Dyad closeness - Inclusion of Other in Self Scale (explanatory mechanism)(Assessed for 8 weeks during intervention period, only in the intervention group, after the daily exercise)
- Dyad listening quality (DPR- listening-quality)(Assessed weekly from week 1 to week 8, after the Dyad practice)
- DPR-Emotions(Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA))
- DPR-Listening-Affect(Assessed weekly from week 1 to week 8, after the Dyad practice)
- Dyad empathic and compassionate listening skills (DPR-listening-skills)(Assessed weekly from week 1 to week 8, after the Dyad practice)