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Digital cognitive behavioral therapy versus Education for chronic pain in adults with sickle cell disease: 12-month
Olubusola B Oluwole1,2, Yi-Fan Chen1,3, Christina M Lalama1,3
1Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, United States.
Background:
Chronic 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.
Methods:
A 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.
Results:
At 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].
Conclusions:
Although 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).