Burnout syndrome
Conditions
Interventions
Product Name: Arctic Root
Product Code: 85-5024
Pharmaceutical Form: Tablet
INN or Proposed INN: p-hydroxyphenyletyl-O-ß-D-glucopyranosyde –A sinnamyl(6-O-a-L-arabinopyranosye)-O-ß-D-glucopyranosideB
Sponsors
Green Medicine AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients in the ages 20 to 55, of both sexes. Referred by a physician and subjectively estimating his/her difficulties as equivalent to the criteria for “fatigue syndrome” suggested by the National board of health and welfare in Sweden. The ICD-code for fatigue syndrome will be F43.8A from 050101. Criteria in appendix 1. These criteria are more conservative than criteria normally used for “burnout”. This will have as a result that all patients included also fulfill criteria for “burnout”. In diagnosing subjects ratings on two fatigue scales (Pine’s burnout measure and Karolinska Utbrändhetsskala) Appendix , a symptom rating and additional questions about time and causes in a questionnaire is used. Diagnosis will be made in one of three ways: 1. Available information is taken into account by a licensed physician which make the diagnosis on basis of all available information including above mentioned subjective data and written referrals. 2. A licensed psychologist meet with the subject for 45 minutes and take into account above mentioned questionnaire and referral. On this basis the psychologist make the diagnosis. 3. A licensed physician meet with the subject 30 minutes and take into account above mentioned questionnaire and referral. On this basis the physician make the diagnosis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluded are subjects with co morbidity of other serious diagnosis. Patients with following diagnosis are excluded: heart disease, stroke, insulin-dependent diabetes, cancer, drug addiction and high consumption of alcohol, stomach ulcers, food- and medication-allergy, asthma, psychosis, depressive episode. Excluded are also high nicotine-consumption, pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvent of physical and psychological stamina.;Secondary Objective: ;Primary end point(s): Primary outcome-measures are Quality of Life measured in some aspects with the SF-36 questionnaire. Perhaps the most used QoL-instrument with good psychometric properties even for the Swedish translation (Persson, Karlsson, Bengtsson, Steen, & Sullivan, 1998; Sullivan, 1994; Sullivan & Karlsson, 1998; Sullivan, Karlsson, & Ware, 1995). Symptom reduction is measured with Pine´s Burnout Measure. A questionnaire with good psychometric properties. The Swedish translation is well used and tested (Hallsten, Bellaagh, & Gustafsson, 2002). The other fatigue and burnout measure which will be used is Karolinska Utbrändhetsskala (Perski, 2002). This scale is under extensive testing right now and the results will be publicized under 2005. This scale has 4 subscales. Montgomery Asberg Depression Rating Scale (MADRS) is a subjective measure of depressive symptoms which is sensitive to change. Good psychometric properties are reported (Montgomery & Asberg, 1979). Stress Medicine Symptom Scale covers 14 stress related somatic symptoms. This is a straight forward symptom likert scale in 7 steps which has good psychometric properties, i.e. reliability over three months (test-retest) and validated against SCL-90s subscale somatisation (Derogatis & Cleary, 1977; Olsson, unpublished data) Cortisol response to awakening is measured with repeated saliva samples according to a principle used in study of burn-out syndrome and Chronic Fatigue Syndrome (de Vente, Olff, van Amsterdam, Kamphuis, & Emmelkamp, 2003; Pruessner, Hellhammer, & Kirschbaum, 1999; Roberts, Wessely, Chalder, Papadopoulos, & Cleare, 2004). Four saliva samples are taken at awakening and 15, 45 and 60 minutes later. The response curve is typically lower in fatigued subjects. | — |
Countries
Sweden
Outcome results
None listed