Co-Principal Investigators: Natoshia Cunningham, Ph.D. and Andrea Knight, MD, MSCE
Funded by: United States Department of Defense
Study Goals: To examine the effect of TEACH on psychological/functional outcomes and disease-related outcomes in youth with cSLE in real-world rheumatology settings versus medical TAU at post assessment (after 8 weeks). To determine longitudinal trajectories (over 1 year) of depressive symptoms, the impact of TEACH, and the association with patient characteristics, psychological/functional and disease-related outcomes. To evaluate TEACH implementation outcomes using a mixed method approach.
Description: This is a multi-site randomized controlled clinical trial with a type 1 effectiveness-implementation hybrid design. The primary aim is to determine the effectiveness of a cognitive behaviourial therapy intervention (TEACH) in real world settings, whereas the secondary aim is to better understand context for implementation into clinical care, for improving psychological/functional outcomes and disease-related outcomes in people with childhood-onset systemic lupus erythematosus (cSLE). 196 eligible participants (approximately 25 participants from each of the 7 sites) will be randomized to receive either the TEACH intervention or continue medical treatment as usual (TAU) for 8 weeks. Participants will complete additional assessments online after 8-weeks, 20-weeks, 32-weeks, 44-weeks, and 56-weeks from baseline.
Impact: This study will have broad implications for SLE models of care in children and adults, and for other rheumatologic conditions. This work will improve healthcare and psychological/functional outcomes and disease-related outcomes for patients with lupus through providing accessible and evidence-based treatments integrated into medical care.