- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474766
Digital Counseling Community for Burnout Prevention (BurnOutCare)
BurnOutCare: an Online Support Community Led by Mental Health Nurses Aimed at Preventing Burnout Among Healthcare Professionals. A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
INTERVENTION The BurnOutCare programme is a 9-week structured intervention delivered via WhatsApp, designed and led by Mental Health Nursing (PMH, RN) professionals in collaboration with clinical psychologists and a consultant psychiatrist.
Channel 1 - WhatsApp Distribution List: Structured content is shared three days per week across four sequential evidence-based modules: Module 1 - Mindfulness (weeks 1-2): guided breathing exercises, body scan meditations, mindful observation, psychoeducation on the neuroscience of stress. Module 2 - Emotional Regulation (weeks 3-4): identification and labelling of emotional states, cognitive restructuring, management of emotional reactivity in clinical settings. Module 3 - Conflict Resolution (weeks 5-6): assertiveness training, active listening, empathy development, strategies for managing workplace conflict. Module 4 - Burnout Prevention (weeks 7-9): recognition of early warning signs, self-care strategies, work-life balance techniques, professional boundary setting. Content formats include short psychoeducational texts, guided audio exercises, brief videos, interactive polls, and infographics, all designed to be consumed in under 10 minutes per delivery.
Channel 2 - Individual Private Channel: A private WhatsApp channel enabling confidential one-to-one interaction, personalised advice, query resolution, and follow-up on disengaged participants.
STATISTICAL ANALYSIS Analysis is conducted in three phases with expert support from the IIS Biobizkaia Biostatistics Team: (1) descriptive statistics with normality testing (Shapiro-Wilk); (2) pre-post outcome comparisons using paired t-tests or Wilcoxon signed-rank tests as appropriate, with effect sizes calculated as Hedges' g or biserial correlation r, both with 95% confidence intervals; (3) exploratory moderator analyses using mixed linear models and repeated-measures ANOVA to assess the influence of gender, years of experience, professional category, perceived workload, job satisfaction, and sleep quality. Significance threshold: p < 0.05.
FUNDING This study is funded by the Convocatoria Intramural Proyectos de Innovación Hasiberri 2024, IIS Biobizkaia (Instituto de Investigación Sanitaria Biobizkaia), Basque Country, Spain. The funding body has no role in study design, data collection, analysis, interpretation, or reporting decisions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bizkaia
-
Usansolo, Bizkaia, Spain, 48960
- Galdakao-Usansolo University Hospital - OSI Barrualde-Galdakao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BurnOutCare Intervention
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.
|
A 9-week structured behavioural intervention delivered via WhatsApp, comprising four evidence-based modules: (1) Mindfulness - breathing techniques, body scan, mindful observation; (2) Emotional Regulation - identification and management of emotions, cognitive restructuring; (3) Conflict Resolution - assertiveness, active listening, empathy; (4) Burnout Prevention - self-care strategies, work-life balance, recognition of burnout signs.
Content formats included interactive surveys, short texts, guided audio exercises, brief videos, and infographics.
An individual private channel provided personalised professional support.
The programme was led by Mental Health Nursing specialists in collaboration with clinical psychology and psychiatry.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Exhaustion
Time Frame: 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.
|
Baseline (pre-intervention) and Week 9 (post-intervention)
|
|
Perceived Stress
Time Frame: 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.
|
Baseline (pre-intervention) and Week 9 (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depersonalisation
Time Frame: Baseline (pre-intervention) and Week 9 (post-intervention)
|
Change in depersonalisation subscale score of the Maslach Burnout Inventory (MBI) from baseline to post-intervention.
Scale range: 0-30; higher scores indicate greater depersonalisation.
|
Baseline (pre-intervention) and Week 9 (post-intervention)
|
|
Personal Accomplishment
Time Frame: Baseline (pre-intervention) and Week 9 (post-intervention)
|
Change in personal accomplishment subscale score of the Maslach Burnout Inventory (MBI) from baseline to post-intervention.
Scale range: 0-48; lower scores indicate reduced personal accomplishment.
|
Baseline (pre-intervention) and Week 9 (post-intervention)
|
|
Programme Satisfaction
Time Frame: Week 9 (post-intervention only)
|
Participant satisfaction with the programme assessed through an ad hoc 6-item Likert scale (1-5 points) evaluating clarity of materials, usefulness for professional practice, quality of interactive activities, perceived impact on well-being, frequency and duration of content delivery, and overall satisfaction.
|
Week 9 (post-intervention only)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Othman SY, Hassan NI, Mohamed AM. Mindfulness-based interventions in critical care nurses. BMC Nursing. 2023;22:305.
- Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, Esmail A. Controlled interventions to reduce physician burnout. JAMA Internal Medicine. 2017;177(2):195-205.
- Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.
- Remor E. Psychometric properties of the Spanish version of the Perceived Stress Scale (PSS). The Spanish Journal of Psychology. 2006;9(1):86-93.
- Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory manual (3rd ed.). Consulting Psychologists Press; 1996.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/25-BurnOutCare
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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