0370: Preliminary Findings from a Randomized Clinical Trial Show a Remotely Delivered Psychological Intervention May Be Beneficial to Youth with Childhood-Onset Lupus
Natoshia Cunningham1, Samantha Ely1, ashley Danguecan2, Mallet Reid3, Alaina Miller4, Mathew Reeves3, Lawrence Ng2, Paris Moaf2, Sarah Mossad2, Tala El Tal5, Luana Flores Pereira2, Deborah Levy6, Linda Hiraki7, Jennifer Stinson2, Sara Ahola Kohut2, khalid abulaban8, Elizabeth Kessler9, Stacy Allen8, Tamar Rubinstein10, Evin Rothschild11, Natalie Rosenwasser12, Kabita Nanda12, Susan Canny12, Emily Smitherman13, Livie Huie13, James Birmingham14, Allison Thompson15, Janel Thompson15, Miranda Moyer15, Angela Chapson Emily Nguyen15 and Andrea Knight5, 1Michigan State University, Grand Rapids, MI, 2The Hospital for Sick Children, Toronto, ON, Canada, 3Michigan State University, East Lansing, MI, 4Wright State University, Dayton, OH, 5The Hospital for Sick Children, Division of Rheumatology, Department of Paediatrics, University of Toronto, Toronto, ON, Canada, 6Division of Rheumatology, The Hospital for Sick Children; Child Health Evaluative Services, SickKids Research Institute; Department of Paediatrics, University of Toronto, Toronto, ON, Canada, 7The Hospital for Sick Children, Division of Rheumatology, Department of Paediatrics, University of Toronto, Genetics and Genome Biology, SickKids Research Institute, Toronto, ON, Canada, 8Spectrum Health, Grand Rapids, MI, 9Spectrum Health Helen DeVos Children's Hospital, Michigan State University, Grand Rapids, MI, 10Albert Einstein College of Medicine, White Plains, NY, 11Children's Hospital at Montefiore, Bronx, NY, 12Seattle Children's Hospital, Seattle, WA, 13University of Alabama at Birmingham, Birmingham, AL, 14Metro Health, Grand Rapids, MI, 15Patient/Caregiver Co-Investigative Team, Grand Rapids, MI
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is often associated with symptoms such as fatigue, pain, and depressive symptoms that contribute to poor health-related quality of life. Cognitive behavioral therapy programs such as the Treatment and Education Approach for Childhood-Onset Lupus (TEACH) have been shown to reduce fatigue and depressive symptoms in pilot testing. However, barriers to access this in-person treatment (e.g., travel distance) were endorsed by participants. In an effort to reduce these barriers, TEACH was adapted to be delivered remotely with the help of a patient/caregiver co-investigative team. This ongoing multisite trial is examining the feasibility of the remotely delivered TEACH program, as well as the effect of TEACH on fatigue, depressive symptoms, and pain compared to standard medical treatment as usual (TAU). The present study examines and reports on interim results from the trial.
Methods: Youth ages 12-22 years meeting the ACR diagnostic criteria for cSLE were referred to the study from seven rheumatology sites across the U.S. and Canada, with a target for 60 patients to complete the study. Participants were screened for clinical elevations in at least one symptom domain using validated measures (fatigue, PROMIS Fatigue T-Score ≥ 60; pain, visual analog scale ≥ 3/10; depressive symptoms, Children's/Beck Depression Inventory T-Score ≥ 60, < 90). Eligible participants complete assessments at baseline and 8 weeks later and are randomized to six-weeks of TEACH and TAU or TAU alone in the interim. TEACH is delivered by a live provider of Zoom and consists of six weekly, one-hour sessions. Recruitment and retention rates were used to assess preliminary feasibility. Paired samples t-tests examined changes in symptoms before and after treatment.
Results: Of the 154 patients approached by providers and research staff, approximately 45% have agreed to participate. Sixty-one participants have completed screening measures, with 47 (77%) qualifying for the study. Three (5%) endorsed severe depressive symptoms, making them ineligible for the study. Retention of enrolled participants remains high (94%). Those who completed TEACH (n = 15) showed significant reductions in fatigue (t(14) = 4.076, p = 0.001, Mpre = 61.3 ± 6.7, Mpost =52.5 ± 6.7) and mood (t(14) = 3.404, p = 0.004, Mpre = 62.4 ± 11.2, Mpost = 53.5 ± 9.7) symptoms, as well as trending reductions in pain (t(14) = 1.947, p = 0.072, Mpre = 3.2 ± 2.2, Mpost = 3.1 ± 1.7) at the post-assessment.
Conclusion: To date, remotely delivered TEACH appears to be feasible as demonstrated by high retention rates. While the present investigation was not adequately powered to compare the effects of TEACH to TAU alone, preliminary analyses signal that TEACH may be beneficial in symptom reduction for youth with cSLE. Future analyses upon the trial's completion will determine whether TEACH is more beneficial than standard medical care alone to manage fatigue, pain, and depressive symptoms in youth with cSLE.
Acknowledgements. We would like to thank the patients, families, and site staff members who have contributed to this study, including Drs. Katelyn Banschbach and Sarah Baxter who have significantly aided in recruitment at the Seattle Children's site.
Disclosures: N. Cunningham, None; S. Ely, None; a. Danguecan, None; M. Reid, None; A. Miller, None; M. Reeves, None; L. Ng, None; P. Moaf, None; S. Mossad, None; T. El Tal, None; L. Flores Pereira, None; D. Levy, None; L. Hiraki, None; J. Stinson, None; S. Ahola Kohut, None; k. abulaban, None; E. Kessler, None; S. Allen, None; T. Rubinstein, None; E. Rothschild, None; N. Rosenwasser, None; K. Nanda, None; S. Canny, None; E. Smitherman, None; L. Huie, None; J. Birmingham, None; A. Thompson, None; J. Thompson, None; M. Moyer, None; A. Emily Nguyen, None; A. Knight, None.
