Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome

Not Applicable

Completed

• Conditions: Efficacy and Tolerance of B-Back® on the Burnout Syndrome
• Interventions: Dietary Supplement: B-Back® placebo (without active compounds)

• Registration Number: NCT01599169
• Lead Sponsor: Université Victor Segalen Bordeaux 2

Brief Summary

The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and Extramel®, on the burnout syndrome.

Detailed Description

The burnout syndrome currently concern all the professional categories. In 2010 the WHO estimated that the three countries with the most important work-related depression are Unites States, Ukraine and France. The direct and indirect costs of work-related stress for the insurance program were not insignificant.

The purpose of this study is to determine the efficacy of the food supplement B-Back® proposed in order to improved the symptoms of the burnout syndrome : stress, fatigue, emotional imbalance, anxiety, sleep, etc.

The main objective is to determine the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Burnout Measure Short version (BMS-10). The others objectives were to evaluate the tolerance of the product, to evaluate the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Maslach Burnout Inventory, depression, and the global quality of professional and family life, sleep,and fatigue (energy).

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-06
• Study First Submitted QC: 2012-05-13
• Study First Posted: 2012-05-15
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-21
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• males and females outpatients aged 30-65 years old
• practicing professionals in contact with patients, students,...
• symptoms suggestive of burnout syndrome
• minimum score to the BMS-10 = 4
• able to understand the sdudy documents
• agreeing to go to dates of controls
• able to give informed consent
• affiliated to a French national insurance program

Exclusion Criteria

• current anxiolytic or antidepressant treatment
• allergy known about one of the components of the food complement in the study
• intolerance in the lactose and in the proteins of milk
• pregnancy or feeding
• progressive pathology involving life-threatening during study
• professional on sick leave
• cancer not stabilized for at least five years or considered as not recovered
• subjects deprived of liberty court decision
• subjects in the psychic incapacity to understand the constraints of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-Back® placebo	B-Back® placebo (without active compounds)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks	baseline and after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BMS-10 score at 6 weeks	baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 6 weeks	baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 12 weeks	baseline and after 12 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks	baseline and after 6 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks	baseline and after 12 weeks
Change from baseline in Beck Depression Inventory score at 6 weeks	baseline and after 6 weeks
Change from baseline in Beck Depression Inventory score at 12 weeks	baseline and after 12 weeks
Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep, fatigue at 6 weeks	baseline and after 6 weeks
Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep,fatigue at 12 weeks	baseline and after 12 weeks

Trial Locations

Locations (1)

Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2; 🇫🇷 Bordeaux, France