Trial reportAnnals of behavioral medicine : a publication of the Society of Behavioral Medicine2026
Digital cognitive behavioral therapy versus Education for chronic pain in adults with sickle cell disease: 12-month randomized trial results.
Trial report in Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04419168 (Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications), which is not on this map. Not yet cited in PubMed.
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Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
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24 authors.
Funding
Abstract
backgroundChronic pain affects up to 40% of adults with sickle cell disease (SCD), yet treatment options remain limited. While cognitive behavioral therapy (CBT) is effective in other chronic pain conditions, it is underutilized for SCD pain, and its effectiveness remains unclear. PURPOSE: The Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) compared digital CBT to Education for chronic SCD pain in adults. At 6 months, the primary outcome (pain interference) showed no between-group difference but both groups improved (CBT: -2.13; Education: -2.66). This report presents 12-month outcomes.
methodsA total of 359 participants with SCD chronic pain were randomized to 12 weeks of digital CBT (n = 181) or Education (n = 178), both with weekly health coach support.
resultsAt 12 months, 56.5% (n = 203) completed follow-up. No between-group differences in pain interference were observed [0.43, 95% CI, -1.61 to 2.48; P = .68]; however, both groups sustained improvement from baseline (CBT: -1.50; Education: -1.93). Cognitive behavioral therapy participants reported greater improvement in emotional impact [2.00, 95% CI, 0.12-3.88; P = .04], while pain intensity, depression, anxiety, and opioid misuse did not differ between groups. Higher health coach engagement was associated with reduced pain interference [-0.073 per 10% increase in engagement; P < .01].
conclusionsAlthough no between-group differences were found, both groups showed sustained improvement in pain interference at 12 months. Personalized support may have contributed to these improvements, highlighting the value of human support within digital interventions. Further research is needed to clarify the relative contributions of digital CBT vs human support. STUDY REGISTRATION: This trial was registered on ClinicalTrials.gov (Identifier: NCT04419168. Registered 06/05/2020). ANALYTIC PLAN REGISTRATION: The trial protocol and analytic plan were pre-registered and are publicly available (https://www.researchprotocols.org/2021/5/e29014).
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