SuRxgWell: Study Protocol for a Randomized Controlled Trial of Telemedicine-based digital Cognitive Behavioral Intervention for high Anxiety and Depression Among Patients Undergoing Elective Hip and Knee Replacement surgery

Abstract

Abstract Background Mood disorders (anxiety, depression) and catastrophizing, lead to increased post-operative pain perception, decreased engagement with physical activity, and increased resource utilization. Studies on perioperative psychological assessment and treatment are scarce. Digital cognitive behavioral intervention (dCBI) such as RxWelläreduces depression in patients with inflammatory bowel disease. We hypothesize that SuRxgWell, the surgical adaptation of RxWellä, can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients undergoing primary total hip and knee arthroplasty (THA, TKA). Methods This randomized, controlled trial will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell. After an informed consent, subjects will be screened using the PROMIS Anxiety/Depression questionnaires. Subjects with a T-score of ≥ 60 will be randomized to either usual care (control group) or SuRxgWell dCBI pre- and perioperative cognitive behavioral intervention via RxWell plus usual care (intervention group). Control group will receive information on how to locate tools to address mood disorders, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months thereafter. The allocation will be 3:1 (intervention: control). Investigators will be blinded, but research coordinators and subjects will not. The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Anxiety/Depression, GAD-7, and PHQ-8. Secondary endpoints include sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function as well as preoperative and postoperative pain scores, pain medication usage, orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery. Subjects will complete a GAD-7 and PHQ-8 questionnaires bi-weekly. Data about RxWell usage and engagement, postsurgical complications, and resource utilization will be recorded. The primary outcome will be analyzed with intention-to-treat estimates and tested using independent two sample t-tests. Discussion We will evaluate dCBI as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery. If effective, this might have important clinical implications towards improving outcomes. Trial Registration clinicaltrials.gov, NCT05658796. Registered 21 December 2022. https://clinicaltrials.gov/ct2/show/NCT05658796