Status:
COMPLETED
Cognitive Behavioural Therapy for Insomnia on Sleep in Rheumatoid Arthritis.
Lead Sponsor:
Bente Appel Esbensen
Collaborating Sponsors:
University of Copenhagen
Rigshospitalet, Denmark
Conditions:
Rheumatoid Arthritis
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease that attacks peripheral joints and posterior tissues. More than half of patients with RA also have insomnia,...
Detailed Description
Introduction: More than half of patients with rheumatoid arthritis has concomitant insomnia. Insomnia may modify pain, fatigue, quality of life and comorbidities which many patients struggle with. To...
Eligibility Criteria
Inclusion
- Diagnosed with RA according to American College of Rheumatology/European League Against Rheumatism criteria 2010
- 18 years of age or older
- Patients with low-to-moderate disease activity (DAS28-CRP ≤ 5.1)
- Sleep score ≥ 2 (DANBIO)
- Insomnia severity Index (ISI) ≥ 11
- Unchanged medical treatment with anti-rheumatics \> 3 months
- No indication for change of medical treatment with anti-rheumatic drugs the next three months
- Understand and read Danish.
Exclusion
- Glucocorticoid administration (i.m., i.a., i.v.) \< four weeks
- Oral glucocorticoid administration \> 5 mg/day
- Change in oral glucocorticoid dose \< three month
- Prior or current contact with rheumatic sleep outpatient clinic
- Night work during the intervention
- Pregnant or breastfeeding
- Current alcohol or drug use disorder
- Patient related circumstances (physical or mental) that impede the ability to give informed consent or adhere to the trial programme.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03766100
Start Date
December 17 2018
End Date
March 8 2021
Last Update
April 19 2021
Active Locations (1)
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1
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases
Glostrup Municipality, Denmark, 2600