A Text Messaging–Enhanced Intervention for African American Patients With Heart Failure, Depression, and Anxiety (TXT COPE-HF): Protocol for a Pilot Feasibility Study
Authors: Cornelius Judith , Whitaker-Brown Charlene , Smoot Jaleesa , Hart Sonia , Lewis Zandria , Smith Olivia 
Published: November 2021

Background
African Americans have a higher incidence rate of heart failure (HF) and an earlier age of HF onset compared to those of other racial and ethnic groups. Scientific literature suggests that by 2030, African Americans will have a 30% increased prevalence rate of HF coupled with depression. In addition to depression, anxiety is a predictor of worsening functional capacity, decreased quality of life, and increased hospital readmission rates. There is no consensus on the best way to treat patients with HF, depression, and anxiety. One promising type of treatment—cognitive behavioral therapy (CBT)—has been shown to significantly improve patients’ quality of life and treatment compliance, but CBT has not been used with SMS text messaging reminders to enhance the effect of reducing symptoms of depression and anxiety in racial and ethnic minority patients with HF.

Objective
The objectives of our study are to (1) adapt and modify the Creating Opportunities for Personal Empowerment (COPE) curriculum for delivery to patients with HF by using an SMS text messaging component to improve depression and anxiety symptoms, (2) administer the adapted intervention to 10 patients to examine the feasibility and acceptability of the approach and modify it as needed, and (3) examine trends in depression and anxiety symptoms postintervention. We hypothesize that patients will show an improvement in depression scores and anxiety symptoms postintervention.

Methods
The study will comprise a mixed methods approach. We will use the eight steps of the ADAPT-ITT (assessment, decision, administration, production, topical expert, integration, training, and testing) model to adapt the intervention. The first step in this feasibility study will involve assembling individuals from the target population (n=10) to discuss questions on a specific topic. In phase 2, we will examine the feasibility and acceptability of the enhanced SMS text messaging intervention (TXT COPE-HF [Texting With COPE for Patients With HF]) and its preliminary effects with 10 participants. The Beck Depression Inventory will be used to assess depression, the State-Trait Anxiety Inventory will be used to assess anxiety, and the Healthy Beliefs and Lifestyle Behavior surveys will be used to assess participants’ lifestyle beliefs and behavior changes. Changes will be compared from baseline to end point by using paired 2-tailed t tests. An exit focus group (n=10) will be held to examine facilitators and barriers to the SMS text messaging protocol.

Results
The pilot feasibility study was funded by the Academy for Clinical Research and Scholarship. Institutional review board approval was obtained in April 2021. Data collection and analysis are expected to conclude by November 2021 and April 2022, respectively.

Conclusions
The study results will add to the literature on the effectiveness of an SMS text messaging CBT-enhanced intervention in reducing depression and anxiety among African American patients with HF.

International Registered Report Identifier (IRRID)
PRR1-10.2196/32550