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Burnout, Healthcare WorkersBurnOutCareNCT07474766

Digital Counseling Community for Burnout Prevention

A study testing BurnOutCare WhatsApp Online Community in people with Burnout, Healthcare Workers and Occupation-related Stress Disorder, run by Osakidetza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
BurnOutCare WhatsApp Online Community
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSpain
Study dates
10 Apr 2025to 5 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Galdakao-Usansolo University Hospital - OSI Barrualde-Galdakao

    Usansolo, Bizkaia, 48960

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
BurnOutCare WhatsApp Online Community
Keywords
Burnout, Healthcare professionals, Primary care, WhatsApp, Online community, Mindfulness, Emotional regulation, Mobile health, Pilot study, Mental health nursing
Medical subject headings
Burnout, Psychological, Psychological Well-Being, Emotional Exhaustion, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BurnOutCare WhatsApp Online CommunityBehavioural

    Also called BurnOutCare, Digital burnout prevention, WhatsApp community intervention

    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.

Study groups in NCT07474766
Study groupRoleWhat they receive
BurnOutCare InterventionExperimentalSingle 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.
Receives: Behavioral: BurnOutCare WhatsApp Online Community

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional Exhaustion

    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.

    Measured: Baseline (pre-intervention) and Week 9 (post-intervention)

  2. Perceived Stress

    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.

    Measured: Baseline (pre-intervention) and Week 9 (post-intervention)

Secondary outcomes (3)
  1. Depersonalisation

    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.

    Measured: Baseline (pre-intervention) and Week 9 (post-intervention)

  2. Personal Accomplishment

    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.

    Measured: Baseline (pre-intervention) and Week 9 (post-intervention)

  3. Programme Satisfaction

    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.

    Measured: Week 9 (post-intervention only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start10 Apr 2025
  3. Primary completion10 Jul 2025
  4. Study completion5 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-group, pre-experimental pilot study with a pretest-posttest design and no control group or randomisation. All eligible volunteers were allocated to the intervention arm. The study was designed as an external pilot to assess the feasibility, acceptability, and preliminary effectiveness of a WhatsApp-based online community for burnout prevention in primary care professionals, prior to the development of a future definitive randomised controlled trial and a purpose-built mobile health application. The intervention consisted of a 9-week structured programme delivered via WhatsApp by Mental Health Nursing professionals, comprising four sequential evidence-based modules: mindfulness, emotional regulation, conflict resolution, and burnout prevention. Content was shared three days per week via a group distribution list, supplemented by an individual private channel for personalised support.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07474766
Sponsor's protocol ID
08/25-BurnOutCare
Acronym
BurnOutCare
Status last verified
Apr 2026
First submitted
8 Mar 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly due to the small sample size of this pilot study, which could compromise participant confidentiality and anonymity. Aggregated and anonymised summary data are reported in the manuscript. Requests for additional information may be directed to the corresponding author (Juan José Pérez Moreno; JUANJOSE.PEREZMORENO@osakidetza.eus).

Publications

  • Othman SY, Hassan NI, Mohamed AM. Effectiveness of mindfulness-based interventions on burnout and self-compassion among critical care nurses caring for patients with COVID-19: a quasi-experimental study. BMC Nurs. 2023 Sep 6;22(1):305. doi: 10.1186/s12912-023-01466-8.

    PubMed 37674145
  • Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, Dawson S, van Marwijk H, Geraghty K, Esmail A. Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Feb 1;177(2):195-205. doi: 10.1001/jamainternmed.2016.7674.

    PubMed 27918798
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

    PubMed 27777223
  • Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

    PubMed 16673626
  • Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory manual (3rd ed.). Consulting Psychologists Press; 1996.

Questions about this trial

What is this clinical trial studying?

A study testing BurnOutCare WhatsApp Online Community in people with Burnout, Healthcare Workers and Occupation-related Stress Disorder, run by Osakidetza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional Exhaustion (time frame: Baseline (pre-intervention) and Week 9 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07474766, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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