Randomised controlled trial of a blended digital mental health intervention for adult anxiety

The randomized controlled trial will include three arms: 1. Blended care (Arm 1): Receives Overcome Anxiety psychological therapy program and access to myNewWay app during 12-week intervention period 2. Self-guided (Arm 2): Receives access to myNewWay app during 12-week intervention period 3. Usual care control (Arm 3): Treatment as usual during 12-week intervention period. BLENDED CARE INTERVENTION (Arm 1: Blended care) The Overcome Anxiety blended care intervention consists of up to 10 online (telehealth) therapy sessions delivered by a psychologist (duration up to 60 minutes). All psychologists participating in the study will hold provisional or full registration as psychologists with Australian Health Practitioner Regulation Agency (AHPRA) and will have received training in using the blended care intervention with their clients. Sessions will be delivered via telehealth on Zoom or telephone over a period of up to 12 weeks. Adherence to the sessions will be monitored using attendance checklists. During the intervention period (12 weeks), Arm 1 participants will also access the myNewWay smartphone app that will supplement in-session treatment (described below). The Overcome Anxiety program is informed primarily by CBT techniques. In each session, participants will learn about key skills to manage anxiety, practice skills over the coming week, and use the smartphone app modules between therapy sessions to consolidate learning. After each session, the participant will complete activities in the smartphone app, summarising key concepts and skills practice for the content covered in the session. The blended care intervention will cover the following topics, across the 10 sessions: 1) understanding anxiety, establishing foundations for change, and goal setting, 2) understanding anxious thinking, 3) developing healthy thinking patterns, 4) overcoming overthinking, 5) facing fears, 6) managing strong emotions, 7) staying well in the long-term. SMARTPHONE APP (Arm 1: Blended care, Arm 2: Self-guided) myNewWay is a free Cognitive Behavioural Therapy (CBT)-based smartphone application that provides therapeutic content and symptom management strategies for adults experiencing symptoms of anxiety and/or depression. Arm 1 & 2 participants will have access to the smartphone app for the whole study duration (24 weeks). Participants will be asked to spend 10 minutes daily completing activities within the app. All activities are delivered with short informative text, the ability to select or provide free text responses and often with engaging illustrations, photos or audio exercises. App analytics will be collected (e.g., number and type of activities completed) to monitor participant engagement and adherence with the smartphone app. The app includes over 60 brief activities that contain the key elements of evidence-based CBT for anxiety, such as psychoeducation, behavioural experiments, exposure therapy, cognitive restructuring, emotion awareness and acceptance, relaxation techniques and mindfulness. All activities are non-sequential, self-paced, take 5 to 15 minutes to complete and are grouped into 10 programs: 1. Two core programs that target anxiety (Overcome anxiety) or depression (Improve your mood) 2. Four programs focus on shared symptoms of anxiety and depression: Healthy thinking (i.e., negative thinking), Manage strong emotions (i.e., emotional regulation), Cope with overthinking (i.e., worry/rumination) and Let go of stress (i.e., body tension). 3. Four mini-programs support long-term recovery from anxiety and depression (Build confidence, Create strong relationships, Enhance mindfulness and Staying well long-term) myNewWay also includes a daily symptom-monitoring tool that tracks mood, anxiety and sleep over time, a quick-access section with brief activities that reduce psychological distress and a Get Help section with support service contact details (e.g., Lifeline, Beyond Blue).