A study into an app to help people with anxiety, from digital therapeutics provider Big Health, has shown positive results in a randomised controlled trial.
The app is a way to manage worry and anxiety, based on cognitive and behavioural techniques, aiming to understand challenges and goals, to guide a person through learning programmes.
The University of Oxford’s Sleep & Circadian Neuroscience Institute and Big Health, has published the results of the randomised controlled trial (RCT) assessing the efficacy and safety of Big Health’s Daylight product in improving symptoms of Generalised Anxiety Disorder (GAD), in the journal Depression and Anxiety.
The study found that Daylight reduced symptoms of anxiety in trial participants, as compared to the control group at six weeks after intervention.
By week 10 follow-up, 71% of Daylight users in the study achieved remission of GAD, as compared to 33% of those in the control group. Improvements were maintained at week 26 (uncontrolled) follow-up.
Professor Jasper Smits, PhD, Department of Psychiatry at the University of Texas, Austin, said: “This trial confirms that Daylight is a safe, effective first-line digital therapeutic for worry and anxiety.”
“The measurable, consistent improvements in mental health status achieved by Daylight users in this trial are significant and meaningful, giving us confidence that as software, Daylight can offer relief to people suffering from worry, anxiety and related conditions.”
Dr. Jenna Carl, vice president of clinical development and medical affairs at Big Health, said: “Anxiety and other mental health challenges cause distress to millions throughout the world, yet many people lack access to effective solutions, due to issues of stigma, or the supply constraints of in-person mental health care which have been further exacerbated by the COVID-19 pandemic.”
“The results of this study confirm that Daylight can have a meaningful impact on the people who need it most. We are excited about the potential for Daylight to help many millions more people back to good mental health, especially those who have limited access to in-person care.”
In the trial, 256 participants were randomised to either use Daylight or be part of a control group which would receive the intervention at a later date. Participants were included based on meeting criteria for GAD with moderate to severe symptoms. Assessments took place at baseline (week 0, immediately preceding randomisation), mid-intervention (week 3 from randomisation), post-intervention (week 6, primary endpoint), follow-up (week 10) and long-term follow-up (week 26 uncontrolled follow-up).