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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41248
Enrollment
144
Registered
2011-03-22
Start date
2013-02-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-Sjögren's sicca syndrome rheumatic diseases consisting of chronic fatigue rheumatoid arthritis and systemic lupus erythematosus Sjögren's syndrome

Interventions

Patients in the treatment group receive a structured outpatient treatment program in a group setting of 6-8 participants. Treatment consists of 16 twice-weekly sessions and one booster session three

Sponsors

Samenwerking Universiteit Utrecht en Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Fatigue

Secondary

MeasureTime frame
Physical functioning, mental wellbeing, subjective and objective dryness of the eyes and mouth, physical activity, sleep,

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)