Anxiety disorders Mental and Behavioural Disorders Anxiety disorders
Conditions
Interventions
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. The
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
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 inte
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. Lack of mobile device or incompatible operating system (Android and iOS compatibility required) 2. Lack of access to Internet 3. Any co-existing medical conditions that could alter the clinical presentation of hyperventilation such as chronic severe asthma or chronic obstructive pulmonary disease 4. Lifetime history of bipolar disorder or psychosis 5. Presence of any Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Axis I disorder, excluding those listed in the inclusion criteria, that are likely to interfere with the patient’s ability to participate in the study, as judged by the investigator 6. Presence of any DSM-IV Axis II disorder that are likely to interfere with the patient’s ability to participate in the study, as judged by the investigator 7. Participants who are acutely suicidal to the degree that precautions against suicide are needed or have a history of suicide attempt in the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of Flowy as an anxiety management intervention, assessed with recruitment and response rates throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Brazil, Canada, Cyprus, Germany, Israel, Italy, Malaysia, United Kingdom, United States of America
Contacts
Public ContactQuynh Pham
Outcome results
None listed