Trial Outcomes & Findings for Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications (NCT NCT04419168)

Only participants who scored \>0 on PHQ-2 (first two items of the PHQ) were administered the rest of the survey.

The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.

At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.

GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.

The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.

The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).

Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.

The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.

At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.

GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.

The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.

The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).

Current Opioid Misuse Measure (COMM) is a self-reported measure to monitor indicators of current aberrant drug-related behaviors in patients with chronic pain on opioid therapy. Total scores are summed across the 9 individual items and range from 0-36, with higher scores representing greater misuse.

Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured opioid medication prescriptions and refills. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured emergency department visits. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured hospitalizations. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.