Clinical trial NCT06626061: Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Burnout, Caregiver
Keywords: Mental health promotion
Caregiver Burnout
CBT Intervention
Stress Management
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2024-10-03
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria :

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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Score of the Emotional Exhaustion Dimension of the Maslach Burnout Inventory (MBI)
timeFrame: 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
Secondary outcomes:
measure: Scores of Depersonalization and Personal Accomplishment from the Maslach Burnout Inventory (MBI).
timeFrame: 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
measure: Perceived stress assessed by the Perceived Stress Scale (PSS-14)
timeFrame: 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
measure: Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS).
timeFrame: 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
measure: Rumination assessed by the Rumination Response Scale. (RRS)
timeFrame: 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
measure: Quality of life at work assessed by the Professional Quality of Life (ProQOL) Scale.
timeFrame: 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
measure: working conditions questionnaire
timeFrame: 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
measure: socio-demographic data questionnaire
timeFrame: 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
measure: A questionnaire on program satisfaction and adherence.
timeFrame: Month 3; Month 6 for the immediate intervention group and Month 6; Month 9 for the delayed intervention group
measure: Coping flexibility
timeFrame: 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
measure: 1 item measuring sleep quality.
timeFrame: 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
measure: 2 items measuring social support:
timeFrame: 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
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie (CHMS)
city: Grenoble
country: France
facility: Centre hospitalier Grenoble Alpes (CHUGA)
Study officials:
affiliation: Université Savoie Mont Blanc
name: Aurélie Gauchet, Professor
role: STUDY_DIRECTOR
affiliation: Université Savoie Mont Blanc
name: Nour Chiboub, doctoral student
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Métropole Savoie (Chambéry)
name: Anne-Sophie Wasmer, Doctor
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire Grenoble Alpes
name: Véronique Bollongeat, Doctor
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire Grenoble Alpes
name: Jean-Luc Bosson, Professor
role: STUDY_CHAIR
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