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

NCT06626061 | Enrolling By Invitation

• 2 other identifiers: 38RC24.03012024-A01832-45
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Burnout, Caregiver

Keywords

Mental health promotion; Caregiver Burnout; CBT Intervention; Stress Management

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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)

  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).

  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)

  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.

  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

Study Arms (3)

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.

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).

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.

Interventions

Cognitive Behavioral Stress management Hybrid Format BEHAVIORAL

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.

Hybrid CBSM Intervention

Cognitive Behavioral Stress management in in person group Format BEHAVIORAL

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.

CBSM Intervention in In-Person Group Format

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Fondation de France: collaborator

Study Sites (2)

Centre Hospitalier Métropole Savoie (CHMS)

Chambéry, France, 73000, France

Location

Centre hospitalier Grenoble Alpes (CHUGA)

Grenoble, France, 38000, France

Location

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MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Aurélie Gauchet, Professor

  Université Savoie Mont Blanc

  STUDY DIRECTOR

• Nour Chiboub, doctoral student

  Université Savoie Mont Blanc

  STUDY DIRECTOR

• Anne-Sophie Wasmer, Doctor

  Centre Hospitalier Métropole Savoie (Chambéry)

  STUDY DIRECTOR

• Véronique Bollongeat, Doctor

  Centre Hospitalier Universitaire Grenoble Alpes

  STUDY DIRECTOR

• Jean-Luc Bosson, Professor

  Centre Hospitalier Universitaire Grenoble Alpes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 3, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)