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Набор скоро начнётся NCT07637422

Online Socio-emotional Dyad Training for Healthcare Professionals' Well-being and Social Skills, Phase II.

Без фазы С лечением Intervention Condition Control Condition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Empathy- and compassion-based socio-emotional mental training (EmCo), Non-randomized waitlist control group (nrWLC).
Кому может быть актуально
Состояния в реестре: Intervention Condition, Control Condition. Базовые параметры: 18 лет — 68 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
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Следующий шаг
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Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Empathy- and compassion-based socio-emotional mental training (EmCo)
    1. Participants engage in a structured 13-minute partner-based contemplative exercise. Each dyad reflects on two experiences from the previous 24 hours: one involving a difficult emotion and one involving gratitude. Partners take turns speaking while the other listens non-judgmentally. During weeks 1-4, the practice emphasizes empathic listening; during weeks 5-8, compassionate listening. Participants are instructed to attend to bodily sensations associated with the emotions described. The pract
  • Другое Non-randomized waitlist control group (nrWLC)
    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.

Первичные конечные точки

  • Depression Anxiety Stress Scale (DASS-21) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Maslach burnout inventory-human services survey (MBI-HSS) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • UCLA Loneliness Scale (UCLA) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Connor Davidson Resilience Scale (CD-RISC) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Social closeness (IOS per profession) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Interprofessionalism Scale (IPAS-D) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Social Support Scale (F-SozU K-6) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Socio-Affective Video Task (SoVT) [Срок оценки: 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)]
  • Sussex-Oxford Compassion Scale for Self and Others (SOCS) [Срок оценки: 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)]
  • Mentalization Scale (MENTS) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
Вторичные конечные точки (12)
  • Positive Affect (Affect Grid) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks of intervention]
  • Emotion Acceptance (EAQ) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Gratitude Questionnaire-6 (GQ-5-G) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Self-Kindness Scale (SCS-SF) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Positive Interpretation Bias (ERT) (explanatory mechanism) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]
  • Weekly-Mentalizing items (explanatory mechanism) [Срок оценки: Assessed thrice a week during the course of 8 weeks]
  • Short Loneliness Scale (SLS) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Perceived Stress (PSS-10) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Depression (PHQ-2) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Empathic Concern & Distress (IRI) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • Trust (KUSIV3) (explanatory mechanism) [Срок оценки: Assessed weekly during the course of 8 weeks]
  • In-group-Out-group bias (ERT) (explanatory mechanism) [Срок оценки: Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)]

Критерии участия

Критерии включения

  • Between 18- and 65-years old.
  • Currently practicing a healthcare profession in Germany or Austria 2a. Belongs to one of the eligible state-regulated professions with legally defined independent responsibility for patient care, including diagnosis, treatment, psychotherapy, maternity care, or the overall nursing process (e.g., physician, psychotherapist, midwife, or registered nurse).

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.

Критерии исключения

(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:

  • Patient Health Questionnaire-9 (PHQ-9 ; Martin et al., 2006 ; Löwe et al., 2004 ; Cutoff ≥ 15 ; or endorsing suicidality on the item 9),
  • Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2007; Spitzer et al., 2006; Cutoff ≥ 15)
  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07637422 · Edu:Social HealthCare Project2

Первоисточники (государственные реестры)

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