Burn Out Clinical Trial
— WELBIOfficial title:
Efficacy and Tolerance of a Specialized Nutraceutical for Pre-burnout - a Randomized, Double Blind Placebo Controlled Study
Verified date | December 2022 |
Source | Institut Pasteur de Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress. Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction. Recently, adaptogen plants have shown promising effects (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) by increasing the body's ability to resist stress and exert a balancing effect on various systems of the body. This study is focused on the effect of a specialized nutraceutical, containing adaptogen plants (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).
Status | Completed |
Enrollment | 100 |
Est. completion date | November 25, 2022 |
Est. primary completion date | November 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - Female or male aged between 30 and 65 years (limits included), - Presenting symptoms of stress, work or emotional overload based on : - COHEN questionnaire (score = 21 allowed the inclusion), - CUNGI questionnaire (part 1: score = 18 allowed the inclusion; part 2: score = 30 allowed the inclusion). Exclusion Criteria: - Suffering from depression based on the Hospital anxiety and depression scale (depression score over 14), - Considered in burn-out, based on MBI questionnaire: - Burnout > 30 - Depersonalization > 12 - Personnal achievement < 33 2 conditions should be fulfilling to exclude participant. - Under nutritional supplement or drugs (psychotropics, betablockers) acting on mental health according to the investigator or stopped less than 3 months before the study. - Diagnose of burn-out for less than 2y. |
Country | Name | City | State |
---|---|---|---|
France | NutrInvest - Institut Pasteur de Lille | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur de Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index) | A self-administered questionnaire. Score from 0 to 10 (from very bad Quality of Life to very good Quality of Life). | 0 day (baseline), 60 days, 120 days | |
Secondary | Hospital Anxiety and depression questionnaire | A self-administered questionnaire:
A: Anxiety. A score over 7 describes an anxious behavior. D: Depression. A score over 7 describes a depressive behavior. |
0 day (baseline) and 120 days | |
Secondary | Cungi questionnaire | This self-administered questionnaire is divided in two parts:
Part 1: stress factor scale. A score = 18 is related to a high perception of environmental stress (many potential sources of stress). Part 2: evaluation stress scale. Scores range from 11 to 66. A score = 30 is related to an intermediate stress score. |
0 day (baseline) and 120 days | |
Secondary | Cohen questionnaire | This self-administered questionnaire contains 10 items. A score = 27 corresponds to a high stress level. | 0 day (baseline) and 120 days | |
Secondary | MBI questionnaire (Maslach Burn Out Inventory Questionnaire) | This self-administered questionnaire will be filled by the subject at V0 and V4 visits.
The questionnaire is subdivided in 3 categories: Professional exhaustion, Depersonalization, Personal achievement. Each category will be analyzed as follow: Section A: Burnout Total 17 or less: Low-level burnout Total between 18 and 29 inclusive: Moderate burnout Total over 30: High-level burnout Section B: Depersonalization Total 5 or less: Low-level burnout Total between 6 and 11 inclusive: Moderate burnout Total of 12 and greater: High-level burnout Section C: Personal Achievement Total 33 or less: High-level burnout Total between 34 and 39 inclusive: Moderate burnout Total greater than 40: Low-level burnout |
0 day (baseline) and 120 days | |
Secondary | PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX) | The PSQI measured sleep quality and disturbances over a one-month interval across one global score and 7 component scores:
Duration of sleep (DURAT) Sleep Disturbance (DISTB) Sleep Latency (LATEN) Day Dysfunction due to sleepiness (DAYDIS) Sleep Efficiency (HSE) Overall Sleep Quality (SLPQUAL) Need Meds to Sleep (MEDS) The global score is calculated by the sum of the 7 subscores: DURAT + DISTB + LATEN + DAYDYS + HSE + SLPQUAL + MEDS. |
0 day (baseline) and 120 days | |
Secondary | SF-36 questionnaire | The SF36 measures health across 8 domains:
Physical function (PF); Role physical (RP); Bodily pain (BP); General Health (GH); Vitality (VT); Social function (SF); Role Emotional (RE); Mental Health (MH). Two component summary measures can be calculated: Physical Composite Score (PCS); Mental Composite Score (MCS). One item considers the general health status (health transition, HT). |
0 day (baseline) and 120 days | |
Secondary | Saliva Cortisol | Saliva will be collected at the following time points at baseline (V0) and after 4 months of product consumption (V4) to analyze the salivary cortisol:
When the subject wakes up 30 minutes after waking up At 20 hours in the evening RIA method was used to analyze cortisol from saliva. |
0 day (baseline) and 120 days |
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