A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations
Study context
- Population
- Patients ages 12–22 years with cSLE presenting to rheumatology clinics from six sites
- Planned comparison
- Six-week remotely delivered TEACH cognitive-behavioral therapy (CBT) program plus treatment as usual (TAU) vs TAU alone
- Primary endpoint
- Feasibility of remotely delivered TEACH
Methodological detailstwo-arm, multisite, remotely delivered intervention, COVID-19 protocol adaptations, Validated measures of fatigue, depressive symptoms and pain at baseline and ≈8 and 20 weeks later; secondary outcome: effect
- Two-arm
- Multisite
- Remotely delivered intervention
- COVID-19 protocol adaptations
- Validated measures of fatigue, depressive symptoms and pain at baseline and ≈8 and 20 weeks later; secondary outcome: effect
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations. Pediatr Rheumatol Online J. Published 23 June 2023. doi:10. 1186/ s12969-023-00835-6
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