Symptoms of fatigue in different patient cohorts
Conditions
Interventions
Group 1: Somatoform disorders (diagnosed somatoform disorder F45.xx)
Group 2: Multiple sclerosis (confirmed MS diagnosis according to the valid McDonald criteria of 2017)
Group 3: Type 1 diabetes mell
Sponsors
Universitätsklinikum Tübingen, Abteilung für Psychosomatische Medizin und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria depend on the respective patient cohorts: Somatoform disorders: Diagnosed somatoform disorder F45.xx Multiple sclerosis: Confirmed MS diagnosis according to the valid McDonald criteria (from 2017) Type 1 diabetes mellitus: Confirmed diagnosis of type 1 diabetes mellitus Malignant tumours: Confirmed diagnosis of a malignant tumour Chronic renal failure: Current dialysis treatment Chronic liver disease: Primary biliary cholangitis or cirrhosis of the liver Child A-C Chronic inflammatory bowel disease: Ulcerative colitis or Crohn's disease Post-COVID: Diagnosis of post-COVID syndrome (at least 1 symptom =12 weeks after infection) Chronic fatigue syndrome: Diagnosis according to Canadian criteria (International Consensus Criteria 2003)
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to all patient cohorts: - Insufficient knowledge of the German language - Pregnancy - Breastfeeding For the multiple sclerosis, type 1 diabetes mellitus, chronic renal failure, chronic liver disease, chronic inflammatory bowel disease, post-COVID and chronic fatigue syndrome cohorts, the following exclusion criterion also applies: - Malignant tumours in the medical history For the multiple sclerosis cohort, the following exclusion criterion also applies: - Indication of a current relapse (within the last 30 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychometric characterisation of fatigue symptoms using various questionnaires (Fatigueometer, Chalder Fatigue Scale, DePaul Symptom Questionnaire Post-Exertional Malaise, Patient Reported Outcomes Measurement Information System, Systemic Exertion Intolerance Disease Criteria of the Institute of Medicine, Short Form Health Survey - Physical Function Subscale; Survey period 08.04.2024 - 31.12.2025) | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression symptoms (Patient Health Questionnaire; PHQ-9), somatization (Patient Health Questionnaire; PHQ-15), somatic symptom disorder (SSD-12), anxiety (generalized anxiety disorder; GAD-7), Distress (National Comprehensive Cancer Network Distress Thermometer), Trauma (Primary Care PTSD Screen; PC-PTSD-5 & Childhood Trauma Questionnaire (CTQ), Quality of life (Short Form Health Survey; SF-12). Pain (Numerical Rating Scale; NRS); Widespread Pain Index (WPI); Work/Occupation (Work Ability Index; WAI), Short Form Effort-Reward Imbalance (ERI), Psychosocial Safety Climate - short (PSC-4) | — |
Countries
Germany
Contacts
Public ContactStephan Zipfel
Universitätsklinikum Tübingen, Abteilung für Psychosomatische Medizin und Psychotherapie
Outcome results
None listed