An interventional study of Cognitive Behavioral Stress management in in person group Format and Cognitive Behavioral Stress management Hybrid Format in Burnout, Caregiver, sponsored by University Hospital, Grenoble. Enrolling by invitation at 2 sites in France. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Prevention
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.
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 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.
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's planned enrollment of 240 is above the median of 73 across 330 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
* 8 CBSM sessions * The sessions will take place in a group setting, face-to-face, within the institution.
Behavioral: Cognitive Behavioral Stress management in in person group Format
* 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).
Behavioral: Cognitive Behavioral Stress management Hybrid Format
Participants will participate in the program at a delayed time to form a control group.
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.
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.
Score of the Emotional Exhaustion Dimension of the Maslach Burnout Inventory (MBI)
The scores for the emotional exhaustion dimension of the Maslach Burnout Inventory (MBI) range from 0 to 54. A higher score indicates a higher level of emotional exhaustion.
Time frame: 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
Scores of Depersonalization and Personal Accomplishment from the Maslach Burnout Inventory (MBI).
The scores for the depersonalization dimension of the Maslach Burnout Inventory (MBI) range from 0 to 30. A higher score indicates a higher level of depersonalization. For the personal accomplishment dimension, scores range from 0 to 48, where a lower score signifies reduced personal accomplishment.
Time frame: 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)
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time frame: 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).
The Hospital Anxiety and Depression Scale (HADS) assesses two dimensions: anxiety (HADS-A) and depression (HADS-D), each with a minimum score of 0 and a maximum score of 21. Higher score indicates significant clinical symptoms of anxiety or depression.
Time frame: 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)
Individual scores on the RSS can range from 5 to 20 for each subscale. (Brooding and reflexion) Higher score reflects a high tendency to ruminate.
Time frame: 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.
Individual scores on the ProQOL can range from 0 to 30. Higher score indicates the following: for Compassion Satisfaction (CS), it reflects a strong joy in helping others; for Burnout (BO), it signifies a high level of professional exhaustion; and for Secondary Traumatic Stress (STS), it denotes a significant level of secondary traumatic stress related to others' experiences.
Time frame: 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
Individual scores on the working conditions questionnaire can range from 0 to 90. Higher score indicates good working conditions.
Time frame: 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
Age, gender, type of hospital service...
Time frame: 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.
It will assess participants' level of satisfaction with the program (e.g., content relevance, usefulness, delivery format) and their engagement (e.g., attendance, completion of exercises). This questionnaire will help identify areas for improvement and better understand participants' experience with the intervention.
Time frame: Month 3; Month 6 for the immediate intervention group and Month 6; Month 9 for the delayed intervention group
Coping flexibility
12-item self-report measure assessing individuals' ability to evaluate and adjust their coping strategies based on their effectiveness. It reflects the dynamic process of stress management, where a person may modify or abandon a strategy if it proves ineffective or harmful. Participants rate each item on a 4-point scale (0 = not applicable to 3 = very applicable). The scale includes three subdimensions: Abandonment - ability to discontinue ineffective coping strategies Re-coping - ability to generate and apply alternative strategies Meta-coping - awareness and evaluation of coping effectiveness A higher total score indicates greater coping flexibility.
Time frame: 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.
"Over the past month, how would you rate the overall quality of your sleep?" 0 = Very poor to 10 = Very good
Time frame: 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:
"Overall, to what extent do you feel supported outside of work (family, friends, etc.)?"( 0 = Very little support to 10 = Very well supported) "Overall, to what extent do you feel supported at work?" ( 0 = Very little support to 10 = Very well supported)
Time frame: 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
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospital, Grenoble