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临床试验/NCT07474766
NCT07474766已完成不适用

BurnOutCare. Design of an Online Community for Burnout Prevention. Preliminary Phase for the Development of a Web/Mobile Application.

Osakidetza1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Emotional Exhaustion

研究概览

简要总结

Burnout syndrome is a serious occupational health problem affecting healthcare professionals worldwide. Defined by emotional exhaustion, depersonalisation, and reduced personal accomplishment, its consequences span mental health (depression, anxiety, insomnia, substance use), physical health (cardiovascular problems, chronic fatigue, gastrointestinal disorders), and professional performance (reduced quality of care, absenteeism, staff turnover). Primary care professionals are a particularly high-risk group due to sustained workload, administrative burden, and limited autonomy.

Despite the availability of evidence-based interventions - including Cognitive Behavioural Therapy, mindfulness, and organisational strategies - their implementation remains limited. Digital tools have shown promising results, but most mobile applications address stress generically and are costly to develop. Online communities via WhatsApp have emerged as an accessible, low-cost alternative with potential to deliver psychoeducational content and peer support effectively.

BurnOutCare is a structured 9-week pilot intervention delivered via WhatsApp, led by Mental Health Nursing professionals, comprising four modules: mindfulness, emotional regulation, conflict resolution, and burnout prevention. Content is shared three times per week using short texts, guided audio exercises, brief videos, interactive surveys, and infographics. A private individual channel provides personalised support.

The study aims to assess the feasibility and preliminary effectiveness of this approach in primary care professionals at OSI Barrualde-Galdakao (Basque Country, Spain), and to generate validated content and evidence to inform the future development of a purpose-built web/mobile health application for burnout prevention.

详细描述

BACKGROUND AND RATIONALE Burnout syndrome, characterised by emotional exhaustion, depersonalisation, and reduced personal accomplishment (Maslach et al., 1996), represents one of the most pressing occupational health challenges in healthcare. Its consequences affect mental health (mood disorders, insomnia, substance use, increased psychotropic medication consumption), physical health (cardiovascular problems, chronic fatigue, migraine, gastrointestinal disorders including Irritable Bowel Syndrome), and work performance (reduced job satisfaction, quality of care, absenteeism, and staff turnover).

Primary care professionals are a particularly high-risk group. A meta-analysis found an overall burnout prevalence of approximately 50% among physicians globally. Primary care workers face specific risk factors: sustained physical and emotional workload, high administrative burden, limited autonomy, chronic time pressure, and reduced institutional recognition. The COVID-19 pandemic further exacerbated pre-existing burnout levels across all healthcare professions.

Evidence-based strategies include individual-focused interventions (CBT, mindfulness-based stress reduction, resilience training) and organisational interventions (workload reduction, improved staffing ratios, supportive team cultures). Digital tools - particularly mobile applications and online communities - have shown promise as accessible, scalable complements to these strategies. WhatsApp-based interventions offer structural advantages: near-universal adoption, no additional installation required, real-time interactivity, low cost, and multimedia content delivery capability. However, most digital tools address stress generically rather than targeting burnout specifically. A preliminary community-based pilot approach - validating content, format, and delivery before full application development - is both methodologically sound and resource-efficient.

STUDY DESIGN AND ETHICS BurnOutCare is a pre-experimental pilot study with a single-cohort pretest-posttest design, without a control group or randomisation. The study adheres to the CONSORT 2010 extension for pilot and feasibility trials (Eldridge et al., 2016), with randomisation-specific items marked as non-applicable. Primary objectives: (1) assess feasibility and effectiveness of the WhatsApp-based intervention; (2) obtain preliminary data to guide future definitive trial design and mobile health application development.

The study was approved by the Research Ethics Committee of OSI Barrualde-Galdakao (Protocol 08/25, Osakidetza-Basque Health Service). All participants provide written informed consent prior to enrolment in accordance with the Declaration of Helsinki and applicable Spanish data protection legislation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

入选标准

  • Active employment within the OSI Barrualde-Galdakao (Osakidetza-Basque Health Service) at the time of the study.
  • Signed written informed consent prior to enrolment.
  • Commitment to active participation in the programme over its 9-week duration.
  • Access to a smartphone and the WhatsApp application

排除标准

  • Non-acceptance of community rules, specifically mutual respect among participants.
  • Use of the community for purposes unrelated to the programme objectives, such as self-promotion or discussion of topics unrelated to burnout prevention.

研究组 & 干预措施

BurnOutCare Intervention

Experimental

Single cohort of primary care professionals who participated in a 9-week WhatsApp-based online community programme led by Mental Health Nursing professionals. The programme included four structured modules: mindfulness, emotional regulation, conflict resolution, and burnout prevention. Content was shared via a WhatsApp distribution list three days per week, and a private individual support channel was available for personalised advice.

干预措施: BurnOutCare WhatsApp Online Community (Behavioral)

结局指标

主要结局

Emotional Exhaustion

时间窗: Baseline (pre-intervention) and Week 9 (post-intervention)

Change in emotional exhaustion subscale score of the Maslach Burnout Inventory (MBI) from baseline to post-intervention. Scale range: 0-54; higher scores indicate greater emotional exhaustion.

Perceived Stress

时间窗: Baseline (pre-intervention) and Week 9 (post-intervention)

Change in total score of the Perceived Stress Scale (PSS, 14 items) from baseline to post-intervention. Scale range: 0-56; higher scores indicate greater perceived stress. Scores between 20-25 indicate moderate stress; scores above 25 indicate high stress.

次要结局

  • Depersonalisation(Baseline (pre-intervention) and Week 9 (post-intervention))
  • Personal Accomplishment(Baseline (pre-intervention) and Week 9 (post-intervention))
  • Programme Satisfaction(Week 9 (post-intervention only))

研究者

发起方
Osakidetza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan José Pérez Moreno

Mental Health Nurse (PMH, RN)

Osakidetza

研究点 (1)

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