Sjögren's syndrome, non-Sjögren's sicca syndrome
Conditions
Interventions
Patients in the treatment group (n=48) receive a structured outpatient treatment program in groups setting of ten participants. Treatment consists of ten sessions within four months and one booster se
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients ≥ 18 years with Sjögren's syndrome who fulfill the European criteria for classification (Vitali et al., 2002). Patients in whom no other cause for dryness was found and who did not fulfill the European classification criteria of Sjögren syndrome, are classified as non-Sjögren's sicca syndrome; 2. A score ≥ 14 on the Multidimensional Fatigue Inventory (MFI); 3. No medication or stable use of regular medication during the intervention; 4. Motivated to participate in a cognitive-behavioural therapy combined with exercise training.
Exclusion criteria
Exclusion criteria: 1. Participation in other (recent) interventions which can possible effect fatigue (i.e. start of using antidepressants during the last half year, or participating in a pharmacological trial); 2. Use of prednisone >10mg per day; 3. Pregnancy; 4. Physical inability to participate in the intervention; 5. Severe psychopathology; 6. Illiteracy or difficulty to communicate in Dutch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes and mediator variables: 1. Physical functioning (physical component summary, PCS of the SF-36); 2. Mental wellbeing (mental component summary, MCS of the SF-36); 3. Subjective disease activity (EULAR Sjögren’s Syndrome Patients Reported Index (ESSPRI)); 4. Physical activity (Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)); 5. Depressive feelings and anxiety (Hospital Anxiety and Depression Scale (HADS)); 6. Self-efficacy concerning fatigue (Self Efficacy Scale-28 (SES-28)); 7. Cognitions about physical activity (Tampa Scale for Kinesiophobia (TAMPA-SK)); 8. Sleep (SLEEP-50); 9. Physical fitness (Single Stage Submaximal Treadmill Walking Test (SSTWT) and the 6-Minute Walking Test (6MWT)); 10. Ocular tear production (Schirmer I test); 11. Salivary production (spitting volume); 12. Disease activity variables: ESR, C reactive protein, IgG, hemoglobin, leukocytes, thrombocyte counts, proinflammatory cytokines, creatinin, ALT, and TSH. | — |
Contacts
Public ContactN. Leeuwen, van
Postbus 80140
Outcome results
None listed