Syrenity App for Depression

Depressive Symptoms Clinical Trial

— SYRA  

Official title:

Mental Health-App for Improving Depressive Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408025
• Other study ID #: 22283
• Secondary ID: 2023-0410
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PHQ-9 >= 10

• Use an iPhone or Android

• Residing in the United States

Exclusion Criteria:

• PHQ-9 item 9 >= 2

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Other:
• Syrenity App
Currently, the Syrenity App has two active interventions. One is an exposure-based intervention called "Face your fears." Another is an intervention based on behavioral activation called "Get better." The app also provides self-report questionnaires for tracking mood along with psychoeducation on a variety of topics relevant to mental health.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Syra Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire 9 (PHQ-9)	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.	6 weeks
Secondary	Generalized Anxiety Disorder Scale-7 (GAD-7)	Anxiety symptoms will be assessed with the GAD-7, a 7-item self-report measure that assesses the frequency of anxiety symptoms. Responses range from 0 ("not at all") to 3 ("nearly every day"), yielding total scores that range from 0-21 with greater scores indicating greater frequency of anxiety symptoms. A score greater than or equal to 10 on the GAD-7 has been identified as a positive screen for anxiety in primary care settings (Spitzer et al., 2006). GAD-7 will be assessed at baseline, and each week of the intervention.	6 weeks
Secondary	Systems Usability Scale (SUS)	The SUS is a brief measure for assessing the usability of given systems (e.g., websites, mobile devices). The SUS has ten items and is rated on a five-point scale with responses ranging from zero ("strongly agree") to four ("strongly disagree"). Scale scores are multiplied by 2.5 to produce scores ranging from zero to 100 with higher scores indicating greater usability. We administered the SUS at the end of the intervention (week 6). However, we also administered a slightly modified version of the SUS at baseline to control for between-individual differences (e.g., the tendency to give high ratings). Participants were asked to rate their prediction of the usability of the book at baseline "based on the small amount of information [they] have on the study."	6 weeks