Social Neuroscience Lab manages the Edu:Social study-based application (app)
Berlin, State of Berlin, 10557, Germany
NCT Number: NCT07637422
Edu:Social Health Care Project Phase II is a non-randomized waitlist-controlled trial with sequential recruitment of the intervention and waitlist control groups (nrWLC), designed to evaluate the effects of a partner-based Dyad-based empathy-compassion mental training (EmCo) intervention on healthcare professionals with regard to 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 healthcare professionals' 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., nurses will practice daily via app with medical doctors or midwives).
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 healthcare professionals' emotional states during their daily partner-based Dyad practice. By combining healthcare professionals' 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 healthcare professionals' 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.
Interested in participating?
Request Info18 year–68 year
All sexes
Interventional
Not applicable
Berlin, State of Berlin, 10557, Germany
Healthcare professionals experience high rates of mental health difficulties, including stress, burnout, anxiety, and depression, with burnout prevalence among physicians and nurses estimated between 30% and over 50% depending on the work context and country. These challenges have intensified in recent years, partly also due to the world-wide Covid19 pandemic, with increased workload, time pressure, and exposure to emotionally demanding situations contributing to elevated psychological distress and reduced well-being. Chronic occupational stress in this population is associated not only with impaired mental health and reduced work engagement but also with decreased quality of care and increased risk of medical errors. Given these high job demands and vulnerabilities, interventions such as mindfulness- and compassion-based programs and socio-emotional training have shown promise in reducing burnout and enhancing resilience and well-being among healthcare professionals. At the same time, these interventions allow to foster social skills such as empathy, compassion and high-quality listening which are essential to healthcare professions.
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 contexts. 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, high-quality listening are core socio-emotional skills in healthcare, supporting effective communication and emotional understanding when providing care for patients across medical and therapeutical domains. 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 in healthcare contexts in an evidence-based manner. To address this gap, the Edu:Social Health Care phase II implements the empathy-compassion Dyad training program (EmCo), which trains a variety of different healthcare professionals to distinguish between empathy (empathic listening), 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 10-week intervention program with weekly online coachings and daily app-based Dyads implemented in the CovSocial project. The ReSource project demonstrated the effectiveness of partner-based dyadic mental training in inducing brain plasticity, while both the ReSource and CovSocial projects showed beneficial effects on reducing stress, enhancing psychological resilience, and strengthening social cohesion across multiple indicators of biopsychosocial health. Unlike the ReSource and CovSocial projects, the present program includes a novel empathy-versus-compassion listening component. 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.
The present study is implemented as a non-randomized controlled trial in a sample of healthcare professionals (target N = 600). 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).
Participants assigned to the EmCo intervention group and the non-randomized waitlist control condition (nrWLC) are recruited concurrently from the same participant pool. After providing informed consent, participants will be pre-screened via a questionnaire and an interview with the intervention trainers. The allocation to empathy-compassion training group (EmCo) or non-randomized waitlist control group (nrWLC) will be based on expressed availability and indicated preference of the participants regarding the two intervention periods for the EmCo Dyad training (option 1: one in autum 2026; option 2: one beginning of 2027) as well as on certain matching criteria, such as gender, age, PHQ-9-scores, to obtain two comparable groups.
All participants will complete a pre-test (T0) assessment phase, including baseline psychometric measures, computer-based tasks, and ecological momentary assessment (EMA). Participants in the intervention group will then attend two onboarding sessions (Onboarding I and II) and complete an 8-week program delivered via a web and smartphone application, including daily Dyad practices and weekly 1.5-hour online coaching sessions with expert mental training teachers. During this period, they will complete weekly self-reports, EMA, and daily pre-post Dyad practice ratings (DPR). The nrWLC will complete EMA and scheduled assessments during the same period. At the end of the first EmCo intervention period, all participants will complete a post-test (T1) assessment comparable to the pre-test. Following completion of the initial post-test (T1), participants in the nrWLC will start their 8-week socio-emotional Dyad intervention (EmCo). The nrWLC will complete additional post-test assessments (T2) after completion of their EmCo training.
The study constitutes Phase II of the Health Care umbrella project, extending the intervention framework previously implemented with healthcare students in Phase I (NCT07407413) to practicing healthcare professionals.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2b. Regular direct contact with patients or clients as part of the professional role (3) Proficient in German. (4) Informed consent. (5) No diagnosis of a psychiatric disorder within the past two years. (6) Stable internet access and necessary technical equipment (mobile phone with internet access).
(7) No regular contemplative practice (≤ 50 hours total within the past six months); healthy population, non-clinical population.
Exclusion criteria
(8) Insufficient German proficiency. (9) Lack of stable internet access or required devices (mobile phone with internet access).
(10) No informed consent. (11) Not currently practicing the profession, or working only in administrative, research, or teaching roles without patient contact.
11a. Professions are excluded if their primary role is supportive, assistive, emergency transport, preventive, counseling-focused, or based on prescribed adjunct therapies rather than independent responsibility for patient care, along with non-human-related professions. This includes, for example, nursing assistants, health psychologists, physiotherapists, occupational therapists, speech therapists, dietitians, massage therapists, paramedics (Sanitäter), and other comparable support or adjunct roles.
11b. No regular direct patient or client contact (12) Regular contemplative practice (> 50 hours in the past six months (e.g., dyad, mindfulness, compassion-based practices).
(13) Current psychiatric diagnosis or therapy, or reaching screening cutoffs on:
Participants in the control group will not receive the intervention. They will complete pre- and post-test procedures consisting primarily of self-report questionnaires, and behavioral tasks, as well as ecological momentary assessment (EMA) conducted on four days within two weeks at pre-test and post-test 1 & 2.
Time frame: 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
Time frame: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
A scale measuring burnout (Maslach, 1996). Higher scores indicate more burnout.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Acoustic assessment of the prosodic speech feature pitch (measured in Hz) during participants' daily Dyad practice, analyzed using audEERING devAIce software.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Acoustic assessment of the prosodic speech feature loudness (unitless) during participants' daily Dyad practice, analyzed using audEERING devAIce software.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Acoustic assessment of the prosodic speech feature speaking rate (measured in syllables per minute) during participants' daily Dyad practice, analyzed using audEERING devAIce software.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Acoustic assessment of the prosodic speech feature intonation (unitless) during participants' daily Dyad practice, analyzed using audEERING devAIce software.
Time frame: 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.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Classification of vocalized emotional expressions intro affect categories during participants' daily Dyad practice, analyzed using audEERING devAIce software. The following parameters will be assessed: angry, happy, and sad, expressed as unitless values ranging from 0 to 1 representing category likelihood.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed weekly during the course of 8 weeks of intervention
Assessment of emotional state (valence) and arousal (Russell et al., 1989). Higher scores on valence and arousal indicate more positive affect and higher arousal.
Time frame: Assessed weekly during the course of 8 weeks
A self-report questionnaire measuring emotional awareness, and acceptance of emotions (Beblo et al., 2011; Kisley et al., 2025).
Time frame: Assessed weekly during the course of 8 weeks
A scale measuring gratitude (Hudecek et al., 2021; McCullough et al., 2002). Higher scores indicate more gratitude.
Time frame: Assessed weekly during the course of 8 weeks
A self-report questionnaire measuring self-kindness and compassionate attitudes toward oneself (Hupfeld & Ruffieux, 2011; Raes et al., 2011). Higher scores indicate greater self-kindness.
Time frame: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
This task assesses the tendency to judge persons' facial expressions more positively using morphed sequences of facial expressions (DeBruine & Jones, 2017; Griffiths et al., 2015). Higher scores indicate a stronger positive interpretation bias.
Time frame: Assessed thrice a week during the course of 8 weeks
Two study-based items measuring the capacity to understand one's own and others' mental states (Dimitrijević et al., 2018). Higher scores indicate greater mentalizing ability.
Time frame: Assessed weekly during the course of 8 weeks
A short scale measuring frequency, intensity, and duration of loneliness (Hughes et al., 2004; Qualter et al., 2021). Higher scores indicate more loneliness.
Time frame: Assessed weekly during the course of 8 weeks
A self-report questionnaire measuring the degree to which situations in one's life are appraised as stressful (Cohen et al., 1983; Klein et al., 2016). Higher scores indicate greater perceived stress.
Time frame: Assessed weekly during the course of 8 weeks
A brief self-report screening measure assessing core depressive symptoms, including depressed mood and anhedonia (Kroenke et al., 2003). Higher scores indicate greater depressive symptom severity.
Time frame: Assessed weekly during the course of 8 weeks
A scale measuring different facets of social emotions, including personal distress and empathic concern (Davis, 1980; Paulus, 2009). Higher scores indicate higher personal distress or empathic concern.
Time frame: Assessed weekly during the course of 8 weeks
A self-report questionnaire measuring generalized interpersonal trust, including trust in others' reliability and integrity (Beierlein et al., 2012). Higher scores indicate greater interpersonal trust.
Time frame: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)
This task assesses the tendency to judge persons from one's own group to be more positive in facial emotion recognition using morphed sequences of facial expressions (DeBruine & Jones, 2017; Griffiths et al., 2015). Higher scores indicate a stronger in-group-out-group bias.
Time frame: Assessed weekly during the course of 8 weeks
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.
Time frame: Assessed for 8 weeks during intervention period, before the daily exercise
Assessment of emotional state (valence) and arousal (Russell et al., 1989) just before starting the Dyad. Higher scores on valence and arousal indicate more positive affect and higher arousal.
Time frame: Assessed for 8 weeks during intervention period, only in the intervention group, after the daily exercise
Assessment of how close participants felt to their Dyad partner (post-Dyad exercise). Higher scores indicate more closeness (Aron et al., 1992; Kinnunen & Windmann, 2013)
Time frame: Assessed for 8 weeks during intervention period, only in the intervention group, after the daily exercise
Assessment of listening involvement (1 custom item; only post-Dyad exercise). Higher scores indicate more listening involvement.
Time frame: Assessed weekly from week 1 to week 8, after the Dyad practice
Custom items (self-generated) measuring the quality of listening to the Dyad partner. Higher scores indicate a higher degree of active, attentive listening.
Time frame: Assessed weekly from week 1 to week 8, after the Dyad practice
Custom items (self-generated) measuring the self-rated skill of listening empathically and compassionately to the Dyad partner's telling of the difficult situation and the event that they are grateful for. Higher scores indicate a higher degree of empathic or compassionate listening respectively.
Time frame: Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)
Emotion intensities (of e.g., happiness, gratitude, sadness, anger) rated by the speaker and by the listener of a Dyad directly after the Dyad.
Time frame: Assessed weekly from week 1 to week 8, after the Dyad practice
Custom items (self-generated) measuring the self-rated affective state during listening to the Dyad partner's telling of the difficult situation and the event that they are grateful for. Higher scores indicate a more positive affect.
Time frame: Assessed before the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms
A scale assessing depression (Löwe et al., 2004; Martin et al., 2006). Higher scores indicate more depression.
Time frame: Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms
A scale assessing generalized anxiety (Spitzer et al., 2006; Löwe et al., 2007). Higher scores indicate more anxiety.
Time frame: Assessed before the intervention, only once, to pre-screen individuals' levels of alexithymia.
A scale assessing alexithymia (Bagby et al., 1994; Ritz & Kannapin, 2000). Higher scores indicate more alexithymia.
Time frame: Assessed before the intervention, only once, to pre-screen individuals' levels of personality disorders symptoms
A self-report scale used to screen personality disorders (Moran et al., 2003; Söchtig et al., 2012)
Time frame: Assessed before the intervention, only once, to collect demographic information
Self-generated demographic items.
Max Planck Social Neuroscience Lab
Other
The Edu:Social Health Care Project Phase II: Investigating the Effects of an Online Socio-emotional Dyad Intervention on Healthcare Professionals' Mental Health, Resilience, Social Competencies and Behaviors.
Acronym: EduSocHealth2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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