Viewing Study NCT06626061



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06626061
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-26

Brief Title: Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
Sponsor: None
Organization: None

Study Overview

Official Title: Promotion of Mental Health and Prevention of Professional Burnout Among Caregivers At Grenoble Alpes University Hospital CHUGA and Savoie Metropolitan Hospital CHMS Through an Intervention Based on Cognitive-behavioral Therapies Aimed At Enhancing Psychosocial Skills
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Caregiver-CBSM
Brief Summary: Stress management among healthcare professionals is crucial for their well-being and the quality of care Exposed to high levels of stress these professionals are at risk of burnout which affects both their health and the quality of the care they provide Studies have shown a high prevalence of burnout among caregivers justifying the need to strengthen preventive health behaviors

This study aims to evaluate the effectiveness of an intervention based on the CBSM Cognitive Behavioral Stress Management program adapted for healthcare professionals in preventing burnout The primary objective is to demonstrate a reduction in emotional exhaustion by the end of the intervention

The study is a prospective multicenter intervention involving medical and non-medical healthcare professionals from CHUGA and CHMS Participants divided into 12 groups of 10 individuals at each institution will follow the program either in collective in-person sessions or in a hybrid format virtual sessions video capsules Some will participate in the program immediately after its implementation while others will complete the program later to serve as a control group Data will be collected at three different points at the start of the program M0 at the end M3 and six months later M6 The primary outcome measures include emotional exhaustion as assessed by the Maslach Burnout Inventory MBI while secondary outcomes cover depersonalization personal accomplishment perceived stress anxiety depression rumination coping strategies work-life quality as well as participant satisfaction and adherence to the intervention

Data analysis will be conducted using analysis of covariance ANCOVA repeated-measures ANOVA multivariate linear regressions and network analyses The study will include 240 healthcare professionals 120 per group divided into 12 groups of 10 participants per institution Participation will last 6 months for the immediate intervention and 9 months for the delayed intervention

The expected outcomes of this study include a significant reduction in emotional exhaustion and improvements in other dimensions of burnout perceived stress anxiety depression and quality of life This research aims to provide evidence on the effectiveness of stress management interventions for healthcare workers with implications for clinical practice and professional training
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 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 The variables studied include the three dimensions of burnout as measured by the Maslach Burnout Inventory MBI-emotional exhaustion depersonalization and personal accomplishment-as well as additional variables such as perceived stress Perceived Stress Scale PSS-14 anxiety and depression Hospital Anxiety and Depression Scale HADS rumination Rumination Response Scale coping strategies Brief-COPE and professional quality of life Professional Quality of Life ProQOL

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 The study involves a total of 240 participants with a minimum of 192 and a maximum of 288 depending on attrition rates evenly distributed between the two hospitals CHUGA and CHMS

Data collection will take place from October 2024 to August 2026 with the last inclusion scheduled for October 2026 The study will last two years with individual participation ranging from six to nine months depending on the intervention group The results are expected to offer practical insights into stress management and burnout prevention among healthcare workers with practical implications for the organization of care in hospital settings The impact of intervention modalities will be studied to determine whether the more accessible and flexible hybrid format provides results comparable to in-person sessions in terms of participant well-being and adherence to the program Furthermore recommendations based on the studys results may be disseminated nationwide to strengthen burnout prevention policies in healthcare institutions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None