A Text Messaging Enhanced Intervention for African American Heart Failure Patients With Depression and Anxiety (TXT COPE-HF): Protocol for a Pilot Feasibility Study (Preprint)

BACKGROUND African Americans have a higher rate of having heart failure (HF) with an earlier age of onset when compared to other racial/ethnic groups. Scientific literature suggests that by 2030 African Americans will have a 30% increased prevalence rate of HF coupled with depression and anxiety. In addition to depression, anxiety is a predictor of worsening functional capacity, decreased quality of life, and increased hospital readmissions. Currently, there is no consensus on the best way to treat HF patients with depression and anxiety. One promising type of treatment-cognitive behavior therapy (CBT) – has shown to significantly improve patients’ quality of life and treatment compliance but CBT has not been used with text messaging reminders to enhance the effect of reducing symptoms of depression and anxiety in minority heart failure patients. OBJECTIVE The purpose of this study is to: 1) Adapt/modify the COPE curriculum for delivery to HF patients using a text-messaging component to improve depression and anxiety symptoms; 2) Administer the adapted intervention to 10 patients to examine feasibility and acceptability of the approach and modify as needed; and 3) Examine trends in depression and anxiety symptoms post-intervention. We hypothesize that patients will show an improvement in depression scores and anxiety symptoms post-intervention. METHODS This study will comprise a mixed methods approach. We will use the 8-steps of the ADAPT-ITT model to adapt the intervention. The first step in this exploratory feasibility research involves assembling individuals of the targeted population (n= 10) to discuss questions on a specific topic. We will gather data in focus groups during both phases by creating an environment that encourages participants to discuss their beliefs, perceptions, and points of view on the COPE for young adults curriculum and its applicability to African-American HF patients with enhanced text messaging reminders (TXT COPE HF). In Phase 2, we will examine the feasibility and acceptability of the enhanced text messaging intervention; (TXT COPE HF) and its preliminary effects with 10 participants. The Beck Depression Inventory will assess depression and the State Trait Anxiety Inventory will assess their anxiety. Changes will be compared from baseline to endpoint using paired t-tests. An exit focus group (n=10) will be held to examine facilitators and barriers with the text messaging protocol. RESULTS The pilot feasibility study was funded in November 2019. Institutional review board approval was delayed due to COVID but was obtained April 2021. Recruitment will occur June to August 2021 and results are expected by December 2021. CONCLUSIONS The findings of this study will add to the body of literature on the treatment of patients with heart failure.