Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
NCT ID: NCT06626061
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
240 participants
INTERVENTIONAL
2025-05-01
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This multicenter study evaluates the effectiveness of the Cognitive Behavioral Stress Management (CBSM) program in preventing burnout. This intervention, based on cognitive-behavioral techniques, integrates stress management tools and relaxation exercises over eight 2-hour sessions. The study aims to recruit 200 healthcare workers, divided into three groups: in-person intervention, hybrid format (videos + videoconferences), and delayed intervention (in-person/hybrid), across two hospital centers (CHUGA and CHMS). Data will be collected at three time points (M0, M3, M6), with emotional exhaustion (MBI) as the primary outcome, supplemented by measures of individual, relational, and organizational factors.
By comparing different intervention modalities (in-person vs. hybrid, immediate vs. delayed), this research will provide practical recommendations to enhance burnout prevention strategies in the hospital setting.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
NCT04667962
Psychological Intervention on Burnout in ICU Caregivers
NCT01959750
Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period : Prospective Cohort.
NCT04349163
Psychological Impact of COVID-19 Outbreak on Caregivers
NCT04511780
Evaluation of the Effectiveness of a Spa Treatment for People With Post-Covid 19 Conditions.
NCT06570239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The current project plans to form 12 groups of 10 people, split between the two institutions, with two intervention modalities: in-person group sessions and a hybrid format. The latter includes podcasts and three virtual sessions (at the beginning, middle, and end of the program). Participants, whether medical or non-medical staff, will complete standardized questionnaires before the intervention begins (M0), at the end of the intervention (M3), and six months later (M6). Data collection will take place from May 2025 to December 2026, with the last inclusion scheduled for October 2026.
All data will be collected via questionnaires:
* The Maslach Burnout Inventory (MBI), which will assess the three dimensions of burnout: emotional exhaustion, depersonalization, and personal accomplishment.
* The Perceived Stress Scale (PSS-14), which will measure the participants' perceived stress levels.
* The Hospital Anxiety and Depression Scale (HADS), which will evaluate symptoms of anxiety and depression among participants.
* The Professional Quality of Life Scale (ProQOL), which will assess participants' professional quality of life.
* The Ruminative Response Scale (RRS), which will evaluate participants' tendencies toward rumination.
* The Coping Flexibility Scale-Revised (CFS-R), which will measure individuals' ability to evaluate the effectiveness of their coping strategies and to replace them when they are not effective.
* A questionnaire on program satisfaction and adherence.
* Sociodemographic data (age, gender, years of experience in the profession) to identify variations in the effectiveness of the intervention based on caregivers' profiles.
* Questions regarding perceptions of working conditions.
* One item measuring sleep quality.
* Two items measuring social support at work and outside of work.
The expected outcomes of this study aim to enrich the scientific literature on burnout prevention and stress management in healthcare professionals, providing recommendations on best practices to be disseminated across healthcare institutions. The results will also be used to develop continuing education programs designed to strengthen healthcare professionals psychosocial skills.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBSM Intervention in In-Person Group Format
* 8 CBSM sessions
* The sessions will take place in a group setting, face-to-face, within the institution.
Cognitive Behavioral Stress management in in person group Format
The CBSM sessions will be delivered to participants in groups of ten, totaling eight sessions, each focused on a specific theme related to stress management. All participants will attend the complete sessions in person.
Hybrid CBSM Intervention
* 8 CBSM sessions
* This format combines podcasts to listen to, along with three online sessions via video conferencing (at the beginning, middle, and end of the program).
Cognitive Behavioral Stress management Hybrid Format
The CBSM (hybrid) sessions will be offered to participants online, including a total of eight video modules, each dedicated to a specific theme related to stress management. Participants will also have access to three interactive virtual sessions, summary sheets in PDF format, and audio recordings for relaxation.
Delayed CBSM Intervention
Participants will participate in the program at a delayed time to form a control group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Behavioral Stress management in in person group Format
The CBSM sessions will be delivered to participants in groups of ten, totaling eight sessions, each focused on a specific theme related to stress management. All participants will attend the complete sessions in person.
Cognitive Behavioral Stress management Hybrid Format
The CBSM (hybrid) sessions will be offered to participants online, including a total of eight video modules, each dedicated to a specific theme related to stress management. Participants will also have access to three interactive virtual sessions, summary sheets in PDF format, and audio recordings for relaxation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Be a volunteer.
* Work at CHUGA or CHMS.
* Be available to attend program sessions (in-person or hybrid).
Exclusion Criteria
* Students in health-related fields.
* Individuals with difficulties in understanding the French language.
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation de France
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aurélie Gauchet, Professor
Role: STUDY_DIRECTOR
Université Savoie Mont Blanc
Nour Chiboub, doctoral student
Role: STUDY_DIRECTOR
Université Savoie Mont Blanc
Anne-Sophie Wasmer, Doctor
Role: STUDY_DIRECTOR
Centre Hospitalier Métropole Savoie (Chambéry)
Véronique Bollongeat, Doctor
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire Grenoble Alpes
Jean-Luc Bosson, Professor
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Grenoble Alpes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Métropole Savoie (CHMS)
Chambéry, France, France
Centre hospitalier Grenoble Alpes (CHUGA)
Grenoble, France, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.
Lopez C, Antoni M, Penedo F, Weiss D, Cruess S, Segotas MC, Helder L, Siegel S, Klimas N, Fletcher MA. A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome. J Psychosom Res. 2011 Apr;70(4):328-34. doi: 10.1016/j.jpsychores.2010.11.010. Epub 2011 Jan 15.
Stagl JM, Antoni MH, Lechner SC, Bouchard LC, Blomberg BB, Gluck S, Derhagopian RP, Carver CS. Randomized controlled trial of cognitive behavioral stress management in breast cancer: a brief report of effects on 5-year depressive symptoms. Health Psychol. 2015 Feb;34(2):176-80. doi: 10.1037/hea0000125. Epub 2014 Jul 28.
Traeger L, Penedo FJ, Benedict C, Dahn JR, Lechner SC, Schneiderman N, Antoni MH. Identifying how and for whom cognitive-behavioral stress management improves emotional well-being among recent prostate cancer survivors. Psychooncology. 2013 Feb;22(2):250-9. doi: 10.1002/pon.2074. Epub 2011 Sep 19.
Antoni MH, Lechner SC, Kazi A, Wimberly SR, Sifre T, Urcuyo KR, Phillips K, Gluck S, Carver CS. How stress management improves quality of life after treatment for breast cancer. J Consult Clin Psychol. 2006 Dec;74(6):1143-52. doi: 10.1037/0022-006X.74.6.1152.
Antoni MH, Wimberly SR, Lechner SC, Kazi A, Sifre T, Urcuyo KR, Phillips K, Smith RG, Petronis VM, Guellati S, Wells KA, Blomberg B, Carver CS. Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention among women undergoing treatment for breast cancer. Am J Psychiatry. 2006 Oct;163(10):1791-7. doi: 10.1176/ajp.2006.163.10.1791.
Baumgarten C, Michinov E, Rouxel G, Bonneterre V, Gay E, Roche PH. Personal and psychosocial factors of burnout: A survey within the French neurosurgical community. PLoS One. 2020 May 29;15(5):e0233137. doi: 10.1371/journal.pone.0233137. eCollection 2020.
Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
Dres M, Copin MC, Cariou A, Mathonnet M, Gaillard R, Shanafelt T, Riou B, Darmon M, Azoulay E. Job Strain, Burnout, and Suicidal Ideation in Tenured University Hospital Faculty Staff in France in 2021. JAMA Netw Open. 2023 Mar 1;6(3):e233652. doi: 10.1001/jamanetworkopen.2023.3652.
Fekete EM, Antoni MH, Schneiderman N. Psychosocial and behavioral interventions for chronic medical conditions. Curr Opin Psychiatry. 2007 Mar;20(2):152-7. doi: 10.1097/YCO.0b013e3280147724.
Hammerfald K, Eberle C, Grau M, Kinsperger A, Zimmermann A, Ehlert U, Gaab J. Persistent effects of cognitive-behavioral stress management on cortisol responses to acute stress in healthy subjects--a randomized controlled trial. Psychoneuroendocrinology. 2006 Apr;31(3):333-9. doi: 10.1016/j.psyneuen.2005.08.007. Epub 2005 Sep 23.
Heritage B, Rees CS, Hegney DG. The ProQOL-21: A revised version of the Professional Quality of Life (ProQOL) scale based on Rasch analysis. PLoS One. 2018 Feb 28;13(2):e0193478. doi: 10.1371/journal.pone.0193478. eCollection 2018.
Lefevre H, Stheneur C, Cardin C, Fourcade L, Fourmaux C, Tordjman E, Touati M, Voisard F, Minassian S, Chaste P, Moro MR, Lachal J. The Bulle: Support and Prevention of Psychological Decompensation of Health Care Workers During the Trauma of the COVID-19 Epidemic. J Pain Symptom Manage. 2021 Feb;61(2):416-422. doi: 10.1016/j.jpainsymman.2020.09.023. Epub 2020 Sep 19.
Marine A, Ruotsalainen J, Serra C, Verbeek J. Preventing occupational stress in healthcare workers. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002892. doi: 10.1002/14651858.CD002892.pub2.
McClafferty H, Brown OW; Section on Integrative Medicine; Committee on Practice And Ambulatory Medicine; Section on Integrative Medicine. Physician health and wellness. Pediatrics. 2014 Oct;134(4):830-5. doi: 10.1542/peds.2014-2278.
Moeini B, Hazavehei SM, Hosseini Z, Aghamolaei T, Moghimbeigi A. The Impact of Cognitive-Behavioral Stress Management Training Program on Job Stress in Hospital Nurses: Applying PRECEDE Model. J Res Health Sci. 2011 Nov 4;11(2):114-20.
Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
Pospos S, Young IT, Downs N, Iglewicz A, Depp C, Chen JY, Newton I, Lee K, Light GA, Zisook S. Web-Based Tools and Mobile Applications To Mitigate Burnout, Depression, and Suicidality Among Healthcare Students and Professionals: a Systematic Review. Acad Psychiatry. 2018 Feb;42(1):109-120. doi: 10.1007/s40596-017-0868-0. Epub 2017 Dec 18.
Rainforth MV, Schneider RH, Nidich SI, Gaylord-King C, Salerno JW, Anderson JW. Stress reduction programs in patients with elevated blood pressure: a systematic review and meta-analysis. Curr Hypertens Rep. 2007 Dec;9(6):520-8. doi: 10.1007/s11906-007-0094-3.
Reis RS, Hino AA, Anez CR. Perceived stress scale: reliability and validity study in Brazil. J Health Psychol. 2010 Jan;15(1):107-14. doi: 10.1177/1359105309346343.
Servant D, Rougegrez L, Barasino O, Demarty AL, Duhamel A, Vaiva G. [Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. Encephale. 2016 Oct;42(5):415-420. doi: 10.1016/j.encep.2016.03.010. Epub 2016 Apr 25. French.
Stagl JM, Bouchard LC, Lechner SC, Blomberg BB, Gudenkauf LM, Jutagir DR, Gluck S, Derhagopian RP, Carver CS, Antoni MH. Long-term psychological benefits of cognitive-behavioral stress management for women with breast cancer: 11-year follow-up of a randomized controlled trial. Cancer. 2015 Jun 1;121(11):1873-81. doi: 10.1002/cncr.29076. Epub 2015 Mar 23.
Tatrow K, Montgomery GH. Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: a meta-analysis. J Behav Med. 2006 Feb;29(1):17-27. doi: 10.1007/s10865-005-9036-1. Epub 2006 Jan 7.
Terp U, Bisholt B, Hjarthag F. Not Just Tools to Handle It: A Qualitative Study of Nursing Students' Experiences From Participating in a Cognitive Behavioral Stress Management Intervention. Health Educ Behav. 2019 Dec;46(6):922-929. doi: 10.1177/1090198119865319. Epub 2019 Aug 8.
Vancappel A, Jansen E, Ouhmad N, Desmidt T, Etain B, Bergey C, d'Ussel M, Krebs MO, Paquet C, Reveillere C, Hingray C, El-Hage W. Psychological Impact of Exposure to the COVID-19 Sanitary Crisis on French Healthcare Workers: Risk Factors and Coping Strategies. Front Psychiatry. 2021 Nov 18;12:701127. doi: 10.3389/fpsyt.2021.701127. eCollection 2021.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-A01832-45
Identifier Type: OTHER
Identifier Source: secondary_id
38RC24.0301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.