ABSTRACT
BACKGROUND: Patients with sickle cell disease (SCD) experience significant medical and psychological stressors that affect their mental health, well-being, and disease outcomes. Digital cognitive behavioral therapy (CBT) has been used in other patient populations and has demonstrated clinical benefits. Although evidence-based, nonpharmacological interventions for pain management are widely used in other populations, these treatments have not been well studied in SCD. Currently, there are no adequately powered large-scale clinical trials to evaluate the effectiveness and dissemination potential of behavioral pain management for adults with SCD. Furthermore, some important details regarding behavioral therapies in SCD remain unclear-in particular, what works best for whom and when. OBJECTIVE: Our primary goal is to compare the effectiveness of two smartphone-delivered programs for reducing SCD pain symptoms: digital CBT versus pain and SCD education (Education). Our secondary goal is to assess whether baseline depression symptoms moderate the effect of interventions on pain outcomes. We hypothesize that digital CBT will confer greater benefits on pain outcomes and depressive symptoms at 6 months and a greater reduction in health care use (eg, opioid prescriptions or refills or acute care visits) over 12 months. METHODS: The CaRISMA (Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications) study is a multisite comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute. CaRISMA is conducted at six clinical academic sites, in partnership with four community-based organizations. CaRISMA will evaluate the effectiveness of two 12-week health coach-supported digital health programs with a total of 350 participants in two groups: CBT (n=175) and Education (n=175). Participants will complete a series of questionnaires at baseline and at 3, 6, and 12 months. The primary outcome will be the change in pain interference between the study arms. We will also evaluate changes in pain intensity, depressive symptoms, other patient-reported outcomes, and health care use as secondary outcomes. We have 80% power to detect a difference of 0.37 SDs between study arms on 6-month changes in the outcomes with 15% expected attrition at 6 months. An exploratory analysis will examine whether baseline depression symptoms moderate the effect of the intervention on pain interference. RESULTS: This study will be conducted from March 2021 through February 2022, with results expected to be available in February 2023. CONCLUSIONS: Patients with SCD experience significant disease burden, psychosocial stress, and impairment of their quality of life. CaRISMA proposes to leverage digital technology and overcome barriers to the routine use of behavioral treatments for pain and depressive symptoms in the treatment of adults with SCD. The study will provide data on the comparative effectiveness of digital CBT and Education approaches and evaluate the potential for implementing evidence-based behavioral interventions to manage SCD pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04419168; https://clinicaltrials.gov/ct2/show/NCT04419168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29014.
ABSTRACT
OBJECTIVE: The purpose of this study was to describe the longitudinal course of eating disorders in patients with borderline personality disorder. METHOD: The SCID I was administered to 290 borderline inpatients and 72 participants with other axis II disorders during their index admission and at five contiguous 2-year follow-up periods. RESULTS: The prevalence of anorexia, bulimia, and eating disorder not otherwise specified (EDNOS) declined significantly over time for those in both study groups but the prevalence of EDNOS remained significantly higher among borderline patients. While over 90% of borderline patients meeting criteria for anorexia, bulimia, or EDNOS at baseline experienced a stable remission by the time of the 10-year follow-up, diagnostic migration was common, particularly for those with anorexia or bulimia. In addition, both recurrences (52%) and new onsets (43%) of EDNOS were more common among borderline patients than recurrences and new onsets of anorexia (28% and 4%) and bulimia (29% and 11%). DISCUSSION: The results of this study suggest that the prognosis for both anorexia and bulimia in borderline patients is complicated, with remissions being stable but migrations to other eating disorders being common. The results also suggest that EDNOS may be the most prevalent and enduring of the eating disorders in these patients.
