Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:31 AM
Study NCT ID:
NCT07474766
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BurnOutCare: WhatsApp Online Community for Burnout Prevention in Primary Care Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D000097815', 'term': 'Emotional Exhaustion'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional Exhaustion', 'timeFrame': 'Baseline (pre-intervention) and Week 9 (post-intervention)', 'description': '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.'}, {'measure': 'Perceived Stress', 'timeFrame': 'Baseline (pre-intervention) and Week 9 (post-intervention)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Depersonalisation', 'timeFrame': 'Baseline (pre-intervention) and Week 9 (post-intervention)', 'description': '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.'}, {'measure': 'Personal Accomplishment', 'timeFrame': 'Baseline (pre-intervention) and Week 9 (post-intervention)', 'description': '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.'}, {'measure': 'Programme Satisfaction', 'timeFrame': 'Week 9 (post-intervention only)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burnout', 'Healthcare professionals', 'Primary care', 'WhatsApp', 'Online community', 'Mindfulness', 'Emotional regulation', 'Mobile health', 'Pilot study', 'Mental health nursing'], 'conditions': ['Burnout, Healthcare Workers', 'Occupation-related Stress Disorder', 'Mental Health', 'Emotional Exhaustion']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Othman SY, Hassan NI, Mohamed AM. Mindfulness-based interventions in critical care nurses. BMC Nursing. 2023;22:305.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Remor E. Psychometric properties of the Spanish version of the Perceived Stress Scale (PSS). The Spanish Journal of Psychology. 2006;9(1):86-93.'}, {'type': 'BACKGROUND', 'citation': 'Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory manual (3rd ed.). Consulting Psychologists Press; 1996.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDespite 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.\n\nBurnOutCare 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.\n\nThe 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.', 'detailedDescription': "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).\n\nPrimary 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.\n\nEvidence-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.\n\nSTUDY 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.\n\nThe 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.\n\nINTERVENTION 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.\n\nChannel 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.\n\nChannel 2 - Individual Private Channel: A private WhatsApp channel enabling confidential one-to-one interaction, personalised advice, query resolution, and follow-up on disengaged participants.\n\nSTATISTICAL 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.\n\nFUNDING 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active employment within the OSI Barrualde-Galdakao (Osakidetza-Basque Health Service) at the time of the study.\n* Signed written informed consent prior to enrolment.\n* Commitment to active participation in the programme over its 9-week duration.\n* Access to a smartphone and the WhatsApp application\n\nExclusion Criteria:\n\n* Non-acceptance of community rules, specifically mutual respect among participants.\n* Use of the community for purposes unrelated to the programme objectives, such as self-promotion or discussion of topics unrelated to burnout prevention.'}, 'identificationModule': {'nctId': 'NCT07474766', 'acronym': 'BurnOutCare', 'briefTitle': 'BurnOutCare: WhatsApp Online Community for Burnout Prevention in Primary Care Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Osakidetza'}, 'officialTitle': 'BurnOutCare. Design of an Online Community for Burnout Prevention. Preliminary Phase for the Development of a Web/Mobile Application.', 'orgStudyIdInfo': {'id': '08/25-BurnOutCare'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BurnOutCare Intervention', 'description': '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.', 'interventionNames': ['Behavioral: BurnOutCare WhatsApp Online Community']}], 'interventions': [{'name': 'BurnOutCare WhatsApp Online Community', 'type': 'BEHAVIORAL', 'otherNames': ['BurnOutCare', 'Digital burnout prevention', 'WhatsApp community intervention'], 'description': '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.', 'armGroupLabels': ['BurnOutCare Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48960', 'city': 'Usansolo', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Galdakao-Usansolo University Hospital - OSI Barrualde-Galdakao', 'geoPoint': {'lat': 43.22166, 'lon': -2.81567}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osakidetza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biobizkaia Health Research Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mental Health Nurse (PMH, RN)', 'investigatorFullName': 'Juan José Pérez Moreno', 'investigatorAffiliation': 'Osakidetza'}}}}