Cognitive-behavioral therapy and exercise training to treat fatigue in Sjögren*s syndrome, non-Sjögren*s sicca syndrome, rheumatoid arthritis and systemic lupus erythematosus, a randomized controlled trial

Completed

• Conditions: non-Sjögren's sicca syndrome; rheumatic diseases consisting of chronic fatigue; rheumatoid arthritis and systemic lupus erythematosus; Sjögren's syndrome; 10003816

• Registration Number: NL-OMON41248
• Lead Sponsor: Samenwerking Universiteit Utrecht en Universitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

- Patients >= 18 years. Patients with Sjögren's syndrome 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. Patients with rheumatoid arthritis fulfill ACR criteria (Amett et al., 1988). Patients with systemic lupus erythematosus fulfill the ACR criteria (Tan et al., 1982).
- A score >= 14 on the Multidimensional Fatigue Inventory (MFI) in a previous questionnaire study (ID = NL24985.041.08);
- No medication or stable use of regular medication during the intervention;
- Motivated to participate in a cognitive-behavioural therapy combined with exercise training.

Exclusion Criteria

- Participation in other (recent) interventions which can possible effect fatigue (i.e. start of using anti-depressants during the last half year, or participating in a pharmacological trial);
- Pregnancy or wish to become pregnant the upcoming year;
- Physical inability to participate in the intervention;
- Severe psychopathology;
- Illiteracy or difficulty to communicate in Dutch.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fatigue</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Physical functioning, mental wellbeing, subjective and objective dryness of the<br /><br>eyes and mouth, physical activity, sleep,</p><br>