Burnout, CaregiverCaregiver-CBSMNCT06626061
Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
A study testing Cognitive Behavioral Stress management in in person group Format and Cognitive Behavioral Stress management Hybrid Format in people with Burnout, Caregiver, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Caregiver
- What is being tested?
- Cognitive Behavioral Stress management in in person group Format and Cognitive Behavioral Stress management Hybrid Format
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- 1 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be a healthcare professional.
- Be a volunteer.
- Work at CHUGA or CHMS.
- Be available to attend program sessions (in-person or hybrid).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Hospitalier Métropole Savoie (CHMS)
Chambéry, 73000
Centre hospitalier Grenoble Alpes (CHUGA)
Grenoble, 38000
About this study
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.
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.
Read the 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.
- Conditions
- Burnout, Caregiver
- Being tested
- Cognitive Behavioral Stress management in in person group Format, Cognitive Behavioral Stress management Hybrid Format
- Keywords
- Mental health promotion, Caregiver Burnout, CBT Intervention, Stress Management
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Stress management in in person group FormatBehavioural
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 FormatBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBSM Intervention in In-Person Group Format | Experimental | * 8 CBSM sessions
* The sessions will take place in a group setting, face-to-face, within the institution. Receives: Behavioral: Cognitive Behavioral Stress management in in person group Format |
| Hybrid CBSM Intervention | Experimental | * 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). Receives: Behavioral: Cognitive Behavioral Stress management Hybrid Format |
| Delayed CBSM Intervention | No intervention | Participants will participate in the program at a delayed time to form a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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...
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Burnout, CaregiverStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Aurélie Gauchet, Professor, Study director, Université Savoie Mont BlancNour Chiboub, doctoral student, Study director, Université Savoie Mont BlancAnne-Sophie Wasmer, Doctor, Study director, Centre Hospitalier Métropole Savoie (Chambéry)Véronique Bollongeat, Doctor, Study director, Centre Hospitalier Universitaire Grenoble AlpesJean-Luc Bosson, Professor, Study chair, Centre Hospitalier Universitaire Grenoble AlpesGérald Gandon, Doctor, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626061
- Sponsor's protocol ID
- 38RC24.0301
- Other IDs
- 2024-A01832-45
- Acronym
- Caregiver-CBSM
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18835434Lopez 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.
PubMed 21414452Stagl 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.
PubMed 25068452Traeger 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.
PubMed 21932396Antoni 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.
PubMed 17154743Antoni 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.
PubMed 17012691Baumgarten 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.
PubMed 32469930Bocerean 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.
PubMed 25511175Carver 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.
PubMed 16250744Dres 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.
PubMed 36976563Fekete 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.
PubMed 17278914Hammerfald 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.
PubMed 16183205Heritage 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.
PubMed 29489875Lefevre 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.
PubMed 32961219Marine 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.
PubMed 17054155
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06626061
- Acronym / sponsor ID
- Caregiver-CBSM / 38RC24.0301
- Conditions
- Burnout, Caregiver
- Keywords
- Mental health promotion, Caregiver Burnout, CBT Intervention, Stress Management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBSM Intervention in In-Person Group Format | Experimental | Behavioral: Cognitive Behavioral Stress management in in person group Format* 8 CBSM sessions * The sessions will take place in a group setting, face-to-face, within the institution. |
| Hybrid CBSM Intervention | Experimental | Behavioral: Cognitive Behavioral Stress management Hybrid 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). |
| Delayed CBSM Intervention | No intervention | –Participants will participate in the program at a delayed time to form a control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be a healthcare professional.
- Be a volunteer.
- Work at CHUGA or CHMS.
- Be available to attend program sessions (in-person or hybrid).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Stress management in in person group FormatThe 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. | Behavioural | CBSM Intervention in In-Person Group Format |
| Cognitive Behavioral Stress management Hybrid FormatThe 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. | Behavioural | Hybrid CBSM Intervention |
Primary outcome
Score of the Emotional Exhaustion Dimension of the Maslach Burnout Inventory (MBI)
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
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.
11 secondary outcomes
Scores of Depersonalization and Personal Accomplishment from the Maslach Burnout Inventory (MBI).
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)
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).
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)
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.
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
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
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.
Time frame: Month 3; Month 6 for the immediate intervention group and Month 6; Month 9 for the delayed intervention group
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.
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:
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 18835434Antoni 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.
- Background: PubMed 21414452Lopez 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.
- Background: PubMed 25068452Stagl 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.
- Background: PubMed 21932396Traeger 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie Gauchet, Professor study director
Université Savoie Mont Blanc
Nour Chiboub, doctoral student study director
Université Savoie Mont Blanc
Anne-Sophie Wasmer, Doctor study director
Centre Hospitalier Métropole Savoie (Chambéry)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Stress management in in person group Format and Cognitive Behavioral Stress management Hybrid Format in people with Burnout, Caregiver, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Emotional Exhaustion Dimension of the Maslach Burnout Inventory (MBI) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626061, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.