Study Testing App to Ease Anxiety Opens Nationwide Enrollment
Investigational therapy uses interactive software to help manage anxiety
The first-of-its-kind Vicore COMPANION Study is now recruiting participants across the U.S. to test Almee, a new artificial intelligence (AI) app designed to help people with pulmonary fibrosis (PF) manage their anxiety.
Developed by Vicore Pharma, Almee is an investigational digital cognitive behavioral therapy (CBT) that uses interactive software instead of a therapist to ease anxiety. The study and app is accessible from anywhere using a smartphone or tablet. The study (NCT05330312) expects to enroll up to 260 PF patients with anxiety, ages 22 and older. No visits to a clinic are required, and participants will be compensated.
“Psychosocial interventions and mental health support such as the tools offered in this study can improve quality of life, enabling patients to better manage the daily challenges of living with PF,” said Andrea Wierzchowski, PhD, a licensed psychologist specializing in neuropsychology, in a press release.
Because of its rarity, patients often experience diagnostic delays and have limited therapeutic options. As a result, people with PF are prone to mental health challenges, such as anxiety, depression, and other problems, all affecting their quality of life.
“PF patients experience higher levels of anxiety, stress and depression compared with the general population,” Wierzchowski said. “The reasons why relate to the rarity and complexity of the condition, the limited therapies available, the delays and misdiagnoses patients experience and an uncertain future.”
According to Wierzchowski, anxiety is marked by feelings of persistent and excessive worries that also manifest as physical symptoms. This can include difficulty concentrating, irritation, confusion, disorientation, sleep disruptions, fatigue, body aches, rapid heartbeat, and further shortness of breath.
Developed under Vicore’s VP04 program, Almee uses AI to deliver CBT, a psychological therapy that aims to identify and correct negative thoughts and help patients change the way they feel. Data from a small pilot study demonstrated the AI app was able of reducing feelings of anxiety by about half.
“Results from a recent pilot study showed that those who accessed the program demonstrated a nearly 50% decrease in anxiety,” said Jessica Shull, director of digital therapeutics at Vicore. “This next phase of the study enables a larger number of patients to participate. It’s also the first of its kind to utilize digital therapeutics for a rare lung disease.”
Open to patients with at least mild anxiety
The California-based study, overseen by pulmonologist Maureen Horton, MD, is open to PF patients with at least mild anxiety, as indicated by a score of 5 or above on the Generalized Anxiety Disorder-7 (GAD-7) scale. On a GAD-7 scale of 0–21, a score of 5–9 indicates mild anxiety, 10–14 moderate anxiety, and 15–21 severe anxiety.
COMPANION will start with a four-week patient satisfaction survey of Almee’s functionality through a semi-structured interview. Then, participants will be randomly assigned to either a therapy or control group.
Therapy involves 10-minute sessions per day plus questionnaires over nine weeks, with suggested activities, while the control group will complete questionnaires and be offered the app after the study’s completion. Questionnaires will be completed using the Curebase online platform. Curebase is a U.S. company running the study on behalf of Vicore.
The study’s primary goal is to lessen anxiety, as indicated by lower GAD-7 scores. Secondary outcomes include assessing changes in anxiety severity through the Hamilton anxiety rating scale (HAM-A), improvements in health-related quality of life, and the occurrence of adverse events.
According to Vicore, company researchers will examine the final data to continue Almee’s development, and personal information will not be shared.