Introduction: Cognitive-behavioral therapy (CBT) for pain is an effective non-pharmacological treatment for chronic pain management, yet can have limited generalizability, access, and reach for underrepresented populations like youth with sickle cell disease (SCD). We aimed to conduct a single-arm proof-of-concept clinical trial to evaluate the feasibility, acceptability, and preliminary efficacy of Back2Life, an adapted, culturally congruent CBT intervention for youth with chronic SCD pain and their parents. We hypothesized that Back2Life would be feasible and acceptable as demonstrated by high levels of treatment engagement (≥80% attendance of treatment sessions) and satisfaction. We also expected clinically significant reductions in pain and pain interference and improvements in pain coping efficacy from baseline to 3-month follow-up (primary endpoint) and 6-month follow-up (maintenance endpoint).
Methods: Youth receiving care at comprehensive SCD clinics at 3 tertiary care locations within a southeast children's hospital were included if they were aged 10-18 years, any SCD genotype, reported chronic pain (i.e., pain on most days per month for at least 3 months), had English fluency, and had stable disease-modifying treatments in the past 3 months. Youth were excluded if they had comorbid medical conditions typically associated with pain but unrelated to SCD, had significant cognitive or developmental limitations that would interfere with study procedures, or received ≥ 3 sessions of outpatient psychological therapy for pain management in the preceding 6 months. Patients completed assessments at baseline, post-treatment, 3-month follow-up, and 6-month follow-up. Primary outcomes included pain characteristics (i.e., intensity, frequency, burden), pain interference, and coping self-efficacy. Secondary outcomes included depressive symptoms, pain catastrophizing, and sleep quality.
The Back2Life program included evidence-based CBT treatment manuals that were adapted based on qualitative feedback from patient and parent stakeholders to optimize the cultural congruence and relevance to chronic SCD pain. Back2Life was an adaptive treatment comprised of 6-10 module-based sessions delivered by a behavioral health coach via telehealth. All participants received 6 core sessions and up to 4 additional sessions were included to optimize tailored treatment components to address individual family needs. Tailored sessions targeted common co-morbidities associated with chronic pain and were identified based on findings of the baseline assessment. Families also could opt-in to tailored sessions based on interest. Descriptive statistics were conducted to evaluate feasibility and acceptability metrics as well as clinically significant changes in primary and secondary clinical outcomes.
Results: Youth (n=20) were on average 15.9 years old (SD=1.6), 50% female, 100% Black or African American, and 95% Non-Hispanic/Latinx. Most (80%) had hemoglobin types HbSS or HbSβ 0. Feasibility and acceptability ratings were high, including 85% consent rate, 80% initiated study procedures, 100% treatment session completion, 93% intervention fidelity, 100% reported moderate-high treatment satisfaction, and strong qualitative feedback suggested treatment acceptance. Patients reported clinically significant changes from baseline to 6-month follow-up in pain frequency (>35% reduction), worst and typical pain intensities (>30% reduction), SCD pain burden (>30% reduction), pain interference (moderate to mild severity), and improvement in pain coping self-efficacy (see Table 1). Patients also reported changes in pain catastrophizing (high to moderate severity), depressive symptoms (mild severity to within normal limits), and no change in sleep quality.
Conclusions: The Back2Life treatment program demonstrated high feasibility and acceptability, participant engagement, participant retention, and meaningful changes in patient-reported outcomes. An adapted, culturally congruent, telehealth-delivered CBT for pain intervention tailored to meet the unique needs experienced by youth with chronic SCD pain can promote increased access, reach, and health equity in SCD.
Disclosures
No relevant conflicts of interest to declare.
