Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications

CaRISMA is a randomized comparative effectiveness trial among adult patients with SCD who report chronic pain (N = 350) randomized to receive either cCBT (n = 175) or m-Education (n = 175). A third group of adult patients with SCD who do not meet the criteria for having chronic pain or who are not interested in participating in the intervention will be a convenience non-chronic pain comparison group and will not receive any intervention or scheduled follow-up. The non-chronic pain comparison group will only complete the battery of questionnaires at baseline and each time they return to the clinic for a medical visit. The study will access patients' stored information or verbally obtained information to assess a person's eligibility and suitability for potential participation in the study.

All adult patients, age 18 or above, with a self-report SCD diagnosis, are willing to complete a brief stress and pain functioning screener (stress/pain screener). The stress/pain screener includes measures of depression, anxiety, disability, pain (intensity, quality, and location), and quality of life. The PHQ-9 and GAD-7 measures are administered as part of routine clinical care at the UPMC comprehensive sickle cell clinic and will both be utilized as part of the stress and pain functioning screener for research purposes in the study. Each patient completes electronic versions of all or some of these scales before the sickle cell clinic social worker or psychologist sees them. The total screener typically takes patients about 15-20 minutes to complete.

Patients who do meet the criteria for having chronic pain will be randomized to one of the two intervention groups. For at least 12 weeks, one group will be asked to engage in a mobile cCBT program tailored for adults with SCD. The second group will receive pain and SCD education on mobile phones (m-Education). Both programs use identical mobile technology platforms; only the content differs. The cCBT program focuses on teaching behavioral coping skills through participants' "seeing and doing" while the pain education arm focuses on improving self-management through participants' "learning and knowing" more about pain and SCD. All participants in the intervention group will have weekly follow-ups with a health coach and will track pain symptoms daily during the intervention. A smartphone is required to participate in the intervention. If an interested and eligible participant does not have a smartphone, one may be provided to them. Upon completion of the study, the participant may keep the phone after completing all study elements, including having the study team remove all study-related data from the phone.

Both arms of the intervention will be delivered through pre-programmed chatbot interactions administered in a mobile messaging app. The intervention arm is automatically assigned via the chatbot. When the CaRISMA intervention is opened for the first time, it will automatically randomize each participant to either study arm: cCBT or m-Education. The participants will not know which arm they have been assigned to, and they will only have access to the materials included in the respective study arm

Participants will receive a link to our online survey tool where they will be asked to respond to a set of questionnaires and Painimation, a novel pain assessment tool.