Flowy randomized controlled pilot trial

INTERVENTION: 1. Intervention group: Flowy is an mHealth game that engages users in a series of mini games where they use breathing retraining exercises and perform diaphragmatic breathing to alleviate anxiety. These mini games range from sailing a boat down a river to flying balloons in the sky. Users touch the screen with their finger as they inhale and remove their finger from the screen as they exhale to control the gaming mechanics. A breathing indicator visually represents a full breath; users see a circle expanding as they inhale and contracting as they exhale. This indicator provides a visual guideline of a breathing retraining exercise, and also simplifies the cognitive assessment of what constitutes a full diaphragmatic breath. The goal of each mini game is to correctly follow the breathing indicator while advancing in the game narrative; users win by breathing correctly and staying calm. No usage guidelines were enforced to allow for assessment of naturalistic use patterns determined by the patient. Flowy also includes an in‐game interactive tutorial on how to properly perform diaphragmatic breathing, as guided by the National Health Service Improving Access to Psychological Therapies protocol alongside evidence‐based research protocol from literature. 2. Control group: participants were placed on a waiting list for 4 weeks. To prevent high attrition rates, participants received a weekly newsletter with curated content on breathing retraining exercises, Flowy game development, mindfulness meditation and similar content relevant to Flowy. Additionally, they received reminder emails through an online marketing tool MailChimp to complete study assessments. After 4 weeks, participants received a free code to download Flowy. CONDITION: Anxiety disorders ; Mental and Behavioural Disorders ; Anxiety disorders PRIMARY OUTCOME: Acceptability of Flowy as an anxiety management intervention, assessed with recruitment and response rates throughout the study SECONDARY OUTCOME: 1. Whether Flowy engaged participants sufficiently to make them proactively use the application, assessed by frequency and duration of use based on log data throughout the study; 2. A significant reduction in anxiety, panic and hyperventilation symptoms and improvement in quality of life reported by participants in the intervention group from baseline to week 4, measured at eligibility prescreen, baseline, week 2 and week 4; 3. A significant reduction in anxiety, panic and hyperventilation symptoms and improvement in quality of life reported by participants in the intervention group compared with the control group from baseline to week 4, measured at eligibility prescreen, baseline, week 2 and week 4; 4. Participant perception of Flowy as a useful intervention, measured with a 21‐question questionnaire that assesses intervention usability and utility at week 4; 5. Assessment of the outcome measure scores in pilot study participants to establish parameters of measurable change in anxiety, hyperventilation and panic attack symptoms for a subsequent full‐powered and full‐scale randomized controlled trial; 6. Study design evaluation to inform sample size calculation and methodology of a subsequent full‐powered and full‐scale randomized controlled trial; ; Anxiety symptoms were assessed with three questionnaires: Generalized Anxiety Disorder‐7 (GAD‐7) item scale, Overall Anxiety Severity and Impairment Scale (OASIS) and Anxiety Sensitivity Index‐3 (ASI‐3).; ; Panic symptoms were assessed with the Panic Disorder Severity Scale‐Self Report (PDSS‐SR). ; ; Hyperventilation symptoms were assessed with the Nijmegen Questionnaire.; ; Quality of life, enjoyment and satisfaction were assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire‐Short Form. INCLUSION CRITERIA: 1. Age at least 18 years old 2. Screen GAD‐7 score =6 3. Screen OASIS score =8 4. Screen ASI‐3 score =16 5. Comorbid disorders including major depression, dysthymia, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, simple phobia, obsessive compulsive disorder, and somatization disorder with moderate symptoms of anxiety 6. Concurrent use of antidepressants, anxiolytics, hypnotics, and herbal products with psychoactive substances acceptable provided there is no change in medication type and dose after randomization 7. Provision of written informed consent 8. Able to comply with the study protocol (e.g., able to download Flowy onto mobile device or able to complete assessments)