ABSTRACT
Objective: To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) is superior to CBT alone or graded aerobic exercise alone. Design/methods: The trial was originally designed as an in-person, group-based treatment with assessments at baseline, mid- and post-treatment, and four follow-up time points. The original study design and methodology was maintained with specific modifications to screening, consenting, assessments, and group-based treatments to be delivered in remote (telehealth) format in response to COVID-19 restrictions. Results: Study enrollment was paused in March 2020 for five months to revise operations manuals, pilot remote treatment sessions for accuracy and fidelity, complete programming of REDCap assent/consent and assessment materials, train study staff for new procedures and obtain regulatory approvals. The trial was relaunched and has been successfully implemented in remote format since July 2020. Trial metrics thus far demonstrate a consistent rate of enrollment, strong attendance at remote treatment sessions, high retention rates and high treatment fidelity after protocol adaptations were implemented. Conclusions: Preliminary findings indicate that FIT Teens protocol adaptations from in-person to remote are feasible and allowed for sustained enrollment, retention, and treatment fidelity comparable to the in-person format. Methodologic and statistical considerations resulting from the adaptations are discussed as well as implications for interpretation of results upon completion of the trial.
ABSTRACT
Objectives: Youth with chronic pain often struggle to function in multiple domains due to pain and associated psychosocial distress. In 2020, schools and businesses shut down and people were encouraged to remain at home due to the COVID-19 pandemic, eliminating or reducing stress due to functional difficulties. This study assessed whether pain and associated psychosocial outcomes improved in youth with chronic pain during the shutdown, compared with before the pandemic. Methods: Patients who completed clinical outcome measures during a multidisciplinary evaluation before the pandemic were readministered the same measures (PROMIS Anxiety, Depression, Sleep Disturbance, PCS, PedsQL) during the shutdown. At follow-up, patients also completed measures of adjustment to COVID-19 and their parents completed a measure of pandemic effects. Results: Participants included 47 patients ages 8-18 and a parent/guardian. The pandemic impacted families in both positive (e.g., more quality time with family) and negative ways (e.g., social isolation, disruption in care). Pain intensity and pain catastrophizing significantly decreased during the shutdown (ps <0.01). Change in pain catastrophizing was correlated positively with change in psychological stress (p = 0.004) and anxiety (p = 0.005) and negatively with change in quality of life (p = 0.024). Discussion: Pain and pain catastrophizing decreased initially during the shutdown related to the COVID-19 pandemic. Change in catastrophizing was associated with change in stress and anxiety. It may be that the reduction in functional demands contributed to this change. Functional difficulties should be addressed in treatment, including pain coping and also environmental modification to support optimal functioning in youth with chronic pain.