Comparison of a Mobile Digital Health Intervention Versus Waitlist Control for the Treatment of Depression and Anxiety: A Randomized Controlled Trial

This research is focused on evaluating mental health outcomes associated with a commercially available programs offered by Sanvello Health compared to a control condition.

Background on the Sanvello program:

Sanvello is a commercially available mobile app designed to teach users strategies to manage their stress, anxiety, and depression. Users can choose which tools they want to use. The strategies are digital implementations of existing practices in psychology such as thought records, mindfulness meditation & relaxation exercises, and behavioral activation. The app also includes features like mood and health tracking to help individuals notice patterns in their moods and adjust their activities to manage their emotions more effectively. Additionally, there is a "hope board" which serves as a place for users to put inspirational quotes, reassuring photos, or save their completed activities to be reminded of their successes in using the app. Finally, the app offers a peer support community, which is a discussion board for users to connect with others going through similar experiences or who share interests. The interventions based on Cognitive-Behavioral Therapy (CBT) include the "Thoughts" tool, which educates users about the effect of thinking errors or "cognitive distortions" on emotions and then prompts users to complete a text-based thought record, identify any cognitive distortions, and then challenge those thoughts (via positive reframe). The "Goals" tool is also based on CBT and allows users to create a list of goals to face their fears (in the case of anxiety) or re-engage with life (for those struggling with depression). The tool helps users to track their tasks and progress. The interventions based on Mindfulness include "Meditations" which provides a suite of activities for users to learn mindfulness, practice deep breathing or body scans, guided relaxation activities, or simply listen to soothing sounds. Sanvello also offers health-behavior tracking which allows users to monitor activities of their choice such as caffeine consumption, exercise, time spent with loved ones, etc. Users can also track their mood state "How are you feeling?". Additionally, users can create and track custom health activities and associate words with their mood from pre-set options such as "stressed" or "happy" or can specify their own words using a hashtag such as "#engaged".

Treatment Groups:

Study participation involves assignment to one of these two groups (app use or waitlist control) and participation in study assessments. The interventions are developed, maintained, and delivered by Sanvello independent of this research study. App use is not prescribed, regulated, or restricted in any way as part of this study; rather, we are interested in collecting app use as outcome data. Primary analyses will be intent-to-treat (i.e., based on group assignment) regardless of app use; app use will also be examined as a covariate during analyses.