Mental Health-App for Improving Depressive Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Indiana University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Patient Health Questionnaire 9 (PHQ-9)
Study Overview
Brief Summary
The goal of this clinical trial is to learn if the Syrenity mental health app reduces depressive symptoms when compared to a control condition. Secondarily, the trial will provide data on the usability and acceptability of the Syrenity app. The main questions it aims to answer are:
Does Syrenity reduce self-reported depressive symptoms compared to a waiting list control? How usable is the Syrenity app?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PHQ-9 >= 10
- •Use an iPhone or Android
- •Residing in the United States
Exclusion Criteria
- •PHQ-9 item 9 >= 2
Arms & Interventions
Syrenity App
The Syrenity App is a mental health app that has been designed to help improve mental health and well-being. The content on the app was created using cognitive-behavioral therapy principles. It uses both active and passive interventions. Active interventions are interventions where the user engages with the app in a back and forth dialogue (e.g., a conversation about restructuring unhelpful thoughts). Passive interventions meanwhile consist of text or videos that the user can read or watch and do not require dialogue with the app.
Intervention: Syrenity App (Other)
Waiting list control
Those assigned to the waiting list control condition will complete weekly surveys as those assigned to the intervention group but will not have access to the Syrenity platform until after the the 6-week trial period.
Outcomes
Primary Outcomes
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 6 weeks
Depression symptoms will be assessed with the PHQ-9. The PHQ-9 is a 9-item self-report measure that assesses the frequency of symptoms of major depressive disorder as outlined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Response options range from 0 ("not at all") to 3 (nearly every day). Total scores on the PHQ-9 range from 0-27 with greater scores indicating greater frequency of depressive symptoms. A score greater than or equal to 10 on the PHQ-9 has been identified as a positive screen for major depression (Kroenke \& Spitzer, 2002). PHQ-9 will be assessed at baseline, and each week of the intervention.
Secondary Outcomes
- Systems Usability Scale (SUS)(6 weeks)
- Generalized Anxiety Disorder Scale-7 (GAD-7)(6 weeks)
Investigators
Lorenzo Lorenzo-Luaces
Associate Professor
Indiana University