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Clinical Trials/NL-OMON41248
NL-OMON41248
Completed
Not Applicable

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 - Management of fatigue in rheumatic diseases

Samenwerking Universiteit Utrecht en Universitair Medisch Centrum Utrecht0 sites144 target enrollmentTBD
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Conditionsnon-Sjögren's sicca syndromerheumatic diseases consisting of chronic fatiguerheumatoid arthritis and systemic lupus erythematosusSjögren's syndrome10003816

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
non-Sjögren's sicca syndrome
Sponsor
Samenwerking Universiteit Utrecht en Universitair Medisch Centrum Utrecht
Enrollment
144
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Samenwerking Universiteit Utrecht en Universitair Medisch Centrum Utrecht

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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