Comparison of a Mobile Digital Health Intervention Versus Waitlist Control for the Treatment of Depression and Anxiety: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4,607
- Locations
- 2
- Primary Endpoint
- Depression scores on the Patient Health Questionnaire-9 (PHQ-9) at end of treatment
Study Overview
Brief Summary
Although mobile applications ("apps") for mental health are popular and widely available, little is known about how well they actually help people with common mental health symptoms of depression, anxiety, and stress. We are partnering with a commercially available app to test how well this app helps people's mental health over 8 weeks. Participants will be randomly assigned (like flipping a coin) to two groups: (a) using the app, (b) no app until after 8 weeks. We will ask participants to complete online surveys about their mood and well-being so we can better understand the effects of these different treatments.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Have a compatible smartphone (Android or Apple)
- •Age 18 or older
- •Ability to read and write English [Justification: (1) limited availability of Sanvello coaches fluent in languages other than English; and (2) use of English language assessments.]
- •Located in the US
- •Clinically significant symptoms of depression and/or anxiety, as evidenced by:
- •Scores of ≥10 on the PHQ-9 depression assessment (Kroenke et al., 2009); and/or
- •Scores of ≥8 on the GAD-7 anxiety assessment (Spitzer et al., 2006)
Exclusion Criteria
- •• Active suicidal ideation
- •History of suicide attempt(s)
- •Current symptoms of:
- •Active substance abuse
- •History of provider diagnosis of:
- •Bipolar disorder ("manic-depression")
- •Intellectual disability
- •Currently in or scheduled to initiate individual psychotherapy to avoid treatment interference.
- •Prior use of Sanvello
- •Psychotropic medication permitted if dose was stable over the past 2 weeks
Outcomes
Primary Outcomes
Depression scores on the Patient Health Questionnaire-9 (PHQ-9) at end of treatment
Time Frame: 8 weeks
Participants self-reported depression symptoms. Scores range from 0 to 27 where higher scores indicate poorer outcomes (more severe depression).
Anxiety scores from the General Anxiety Disorder-7 (GAD-7) at the end of treatment
Time Frame: 8 weeks
Participants self-reported anxiety symptoms. Scores range from 0 to 21 where higher scores indicate poorer outcomes (i.e., more severe anxiety).
Secondary Outcomes
- Health-related quality of life scores from The Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure at the end of treatment(8 weeks)
Investigators
Brenna Renn
Dr. Brenna Renn, Principal Investigator
University of Nevada, Las Vegas