Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout

Официальное название

Promotion of Mental Health and Prevention of Burnout Among Caregivers at CHU Grenoble Alpes (CHUGA) and CH Métropole Savoie (CHMS) Through a Stress Management Intervention Based on Cognitive Behavioral Therapies.

Обзор

Professional burnout is a common syndrome among healthcare workers, impacting both their well-being and the quality of care provided . It is characterized by emotional exhaustion, depersonalization, and a reduced sense of personal accomplishment. 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.

Подробное описание

This project aims to evaluate the effectiveness of the Cognitive Behavioral Stress Management (CBSM) program in preventing burnout, a widespread issue among healthcare professionals. Burnout, particularly characterized by emotional exhaustion, depersonalization, and reduced personal accomplishment, has severe consequences on caregivers' mental and physical health as well as the quality of care provided. In this context, the CBSM program, originally developed for patients, has been modified and adapted specifically to meet the needs of healthcare professionals. It is a multidimensional program combining various techniques such as relaxation, cognitive and emotional management, coping strategies and enhancement of social support and assertiveness. Numerous previous studies have demonstrated the effectiveness of CBSM in reducing stress, anxiety, and depressive symptoms, as well as in improving the long-term quality of life of participants.

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Score of the Emotional Exhaustion Dimension of the Maslach Burnout Inventory (MBI) [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]

Вторичные конечные точки (11)

• Scores of Depersonalization and Personal Accomplishment from the Maslach Burnout Inventory (MBI). [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• Perceived stress assessed by the Perceived Stress Scale (PSS-14) [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS). [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• Rumination assessed by the Rumination Response Scale. (RRS) [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• Quality of life at work assessed by the Professional Quality of Life (ProQOL) Scale. [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• working conditions questionnaire [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• socio-demographic data questionnaire [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• A questionnaire on program satisfaction and adherence. [Срок оценки: Month 3; Month 6 for the immediate intervention group and Month 6; Month 9 for the delayed intervention group]
• Coping flexibility [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• 1 item measuring sleep quality. [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]
• 2 items measuring social support: [Срок оценки: Month 0; Month 3; Month 6 for the immediate intervention group and Month 0; Month 3; Month 6; Month 9 for the delayed intervention group]

Критерии участия

Критерии включения

• Be a healthcare professional.
• Be a volunteer.
• Work at CHUGA or CHMS.
• Be available to attend program sessions (in-person or hybrid).

Критерии исключения

• Protected persons (articles L1121-5 to L1121-8 of the Public Health Code), except for pregnant women for whom a benefit is expected in relation to a foreseeable minor risk for the pregnant woman or the unborn child.
• Students in health-related fields.
• Individuals with difficulties in understanding the French language.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 2 центра

• Centre Hospitalier Métropole Savoie (CHMS) — Chambéry
• Centre hospitalier Grenoble Alpes (CHUGA) — Grenoble

Публикации

• 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. PMID 18835434
• 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. PMID 21414452
• 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. PMID 25068452
• 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. PMID 21932396
• 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. PMID 17154743
• 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. PMID 17012691
• 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. PMID 32469930
• 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. PMID 25511175

Идентификаторы

NCT: NCT06626061 · 38RC24.0301 · 2024-A01832-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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