Abstract
Sickle cell anemia is a blood problem that runs in families. It makes red blood cells shaped like crescent moons, which can hurt the body and cause episodes of severe pain called vaso-occlusive crises (Inusa et al., 2019). Most people with SCA have much pain often that is hard to control with medicine. This research looks at how a type of therapy called cognitive behavioral therapy can help manage pain for people with sickle cell anemia. We will ask 30 adults with sickle cell anemia who have at least two painful episodes each year to join our study. They will be recruited from a clinic that specializes in blood disorders. People will be put into a group by chance. One group will do a six-week program to learn how to cope with pain. The other group will get regular care, but they will have to wait. During CBT sessions, you will learn how to think differently, relax, and set goals to help you deal with sickle cell pain. We will check how much the pain is bothering you at the beginning, after treatment, and later using a questionnaire. Researchers believe that people with sickle cell anemia who receive cognitive behavioral therapy will have much better pain relief than those who do not receive it. The results will help explain how using psychological methods along with traditional pain treatment could help patients with serious needs. Assessing how well CBT works can help improve the lives of people with this difficult, long-lasting condition.
Introduction
Sickle cell anemia is a disease you inherit that affects the shape of your red blood cells and can cause much pain. Many people with Sickle Cell Anemia experience much pain, which affects their quality of life (Bogart et al., 2022). Over 75% of patients report this. Pain has a big impact, but doctors cannot do much about it right now. Painkillers do not always work well and can have bad effects. There are few other options for treating pain.
There has been recent interest in incorporating cognitive-behavioral and psychosocial elements into pain care models for SCA patients to provide additional coping support. Cognitive behavioral therapy (CBT) aims to modify thought patterns, emotions, behaviors, and skills to manage pain better. CBT interventions have successfully reduced pain severity and improved functioning across conditions like arthritis, cancer pain, and chronic low back pain. Emerging evidence suggests CBT may confer similar benefits for SCA populations. An 8-session group CBT program focused on building adaptive pain coping abilities led children and adolescents with SCA to report decreased pain severity post-treatment and at 3-month follow-up compared to standard care alone. However, there remains limited recent research on implementing such psychological pain management interventions in adults with SCA specifically.
This study will address this gap through a randomized controlled trial evaluating a tailored 6-week individual CBT program for pain coping skills training versus standard care in adults with SCA experiencing frequent vaso-occlusive pain crises. Results will provide needed insights into whether integrated CBT protocols can enhance pain outcomes in an underserved population with significant unmet pain management needs.
Hypothesis
This study puts forth the hypothesis that adult sickle cell anemia (SCA) patients who undergo a 6-week individual cognitive behavioral therapy (CBT) program tailored specifically to build pain coping skills and abilities will report significantly greater reductions in perceptions of pain severity and degree of pain interference in daily living activities at 1-, 3-, and 6-month follow-up assessments compared to a control group of SCA patients receiving only standard medical care on a waitlist (Tisdale et al., 2020). Standard care for SCA-related pain currently relies predominantly on pharmacological approaches, which are often inadequate for managing the multifaceted, recurrent acute pain crises these individuals face. CBT aims to address psychosocial dimensions impacting the pain experience through objective modification of thought and behavior patterns. It is expected that with CBT’s demonstrated success in similar chronic pain populations, focusing CBT techniques directly on the unique pain coping challenges those with SCA encounter could provide additional, measurable improvements in pain outcomes over time, supplemental to standard treatment alone. Assessing CBT’s potential benefits for this patient group is vital given the profound, often unrelenting pain SCA patients withstand and the frequent failings of current pain management paradigms. Using longitudinal follow-up allows analysis of whether any CBT-related gains are maintained long-term and attests to the viability of incorporating psychological programs into routine care for an extremely underserved population.
Method
This study will use a random method to test if a 6-week therapy that helps people with sickle cell anemia cope with pain is better than the usual care they get. We are looking for 30 adults with sickle cell anemia who go to the doctor at least two times a year for severe pain. If you fit this description and are 18 or older, we want you to join our study. We will not accept people with serious problems in thinking, learning, or mental health issues like thinking or mood disorders for the program.
Upon recruitment, participants will provide demographic information and complete baseline quantitative evaluations of their SCA pain utilizing the McGill Pain Questionnaire, a well-validated measure that assesses sensory, affective, evaluative, and miscellaneous pain indices that provide robust metrics of clinical pain experience. Participants will then be randomly assigned in a 1:1 ratio to receive either the tailored 6-week CBT intervention or a waitlist control condition, continuing to receive standard medical care. Those in the CBT arm will partake in hour-long individual CBT sessions held weekly for six consecutive weeks, focusing directly on building cognitive and behavioral skills specific to adapting to recurrent, severe SCA pain, such as cognitive restructuring techniques to shift maladaptive thought patterns, relaxation skills to mitigate pain-related distress, goal setting, and activity pacing at home.
Upon conclusion of the 6-week study period, all participants will repeat the McGill Pain Questionnaire as well as at follow-ups one month, three months, and six months post-intervention. Changes in composite pain severity and interference scores will be analyzed using a 2×4 mixed analysis of variance (ANOVA) to discern differences in trajectory between the CBT and control groups. It is hypothesized that those undergoing CBT will exhibit statistically significantly greater reductions in all facets of SCA pain at all follow-up time points relative to the standard care control condition.
References
Inusa, B., Hsu, L., Kohli, N., Patel, A., Ominu-Evbota, K., Anie, K., & Atoyebi, W. (2019). Sickle Cell Disease—Genetics, Pathophysiology, Clinical Presentation and Treatment. International Journal of Neonatal Screening, 5(2), 20. https://doi.org/10.3390/ijns5020020
Alsabri, M., Carfagnini, C., Amin, M., Castilo, F., Lewis, J., Ashkar, M., Hamzah, M., Mohamed, N., Saker, M., Mahgerefteh, J., St. Victor, R., Peichev, M., Kupferman, F., & Viswanathan, K. (2023). Complementary and alternative medicine for children with sickle cell disease: A systematic review. Blood Reviews, 59, 101052. https://doi.org/10.1016/j.blre.2023.101052
Bogart, K., Hemmesch, A., Barnes, E., Blissenbach, T., Beisang, A., Engel, P., Tolar, J., Schacker, T., Schimmenti, L., Brown, N., Morrison, K., Albright, T., Klein, M., Coleman, J., Nelsen, K., Blaylark, R., LaFond, K., Berkowitz, S., Schultz, K. A., & Hansen, K. (2022). Healthcare access, satisfaction, and health-related quality of life among children and adults with rare diseases. Orphanet Journal of Rare Diseases, 17(1). https://doi.org/10.1186/s13023-022-02343-4
Tisdale, J. F., Thein, S. L., & Eaton, W. A. (2020). Treating sickle cell anemia. Science, 367(6483), 1198–1199. https://doi.org/10.1126/science.aba3827
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