Digital cognitive behavioral therapy vs education for pain in adults with sickle cell disease

Abstract

Despite the burden of chronic pain in sickle cell disease (SCD), nonpharmacological approaches remain limited. This multisite, randomized trial compared digital cognitive behavioral therapy (CBT) with a digital pain/SCD education program ("Education") for managing pain and related symptoms. Participants were recruited virtually from seven SCD centers and community organizations in the United States. Adults (aged ≥18 years) with SCD-related chronic pain and/or daily opioid use were assigned to receive either CBT or Education for 12 weeks. Both groups used an app with interactive chatbot lessons and received personalized health coach support. The primary outcome was the change in pain interference at six months, with secondary outcomes including pain intensity, depression, anxiety, quality of life, and self-efficacy. Of 453 screened participants, 359 (79%) were randomized to CBT (n = 181) or Education (n = 178); 92% were Black African American, and 66.3% were female. At six months, 250 participants (70%) completed follow-up assessments, with 16 (4%) withdrawals. Engagement with the chatbot varied, with 76% connecting and 48% completing at least one lesson, but 80% of participants completed at least one health coach session. Both groups showed significant within-group improvements in pain interference (CBT: -2.13; Education: -2.66), but no significant difference was observed between them (mean difference, 0.54; P = .57). There were no between-group differences in pain intensity, depression, anxiety, or quality of life. High engagement with health coaching and variable engagement with digital components may explain the similar outcomes between interventions in this diverse, hard-to-reach population.

Graphical abstract

Figure 1.

CONSORT flow diagram of CaRISMA trial. Participant flow through screening, randomization, allocation, and follow-up. Numbers of participants screened and randomly assigned to CBT or Education arms, completed assessments, missed follow-ups, and withdrawals at 3 and 6 months are shown. LTF, lost to follow-up. For potential participants that were not interested in the intervention study, they were offered enrollment in the "Comparison Group" that required participants complete questionnaires only. Data for comparison group is not reported. LTF, Lost to follow up.