Syrenity App for Depression

NCT06408025 | Enrolling By Invitation

• 2 other identifiers: 222832023-0410
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Generalized Anxiety Disorder Scale-7 (GAD-7)

  6 weeks

• Systems Usability Scale (SUS)

  6 weeks

Study Arms (2)

Syrenity App

EXPERIMENTAL

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.

Other: Syrenity App

Waiting list control

NO INTERVENTION

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.

Interventions

Syrenity App OTHER

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.

Syrenity App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PHQ-9 \>= 10
• Use an iPhone or Android
• Residing in the United States

You may not qualify if:

• PHQ-9 item 9 \>= 2

Sponsors & Collaborators

• Indiana University: lead
• Syra Health: collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47408, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 15, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)