Depressive SymptomsSYRANCT06408025
Syrenity App for Depression
A study testing Syrenity App in people with Depressive Symptoms, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Syrenity App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9 >= 10
- Use an iPhone or Android
- Residing in the United States
Who cannot join
- PHQ-9 item 9 >= 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health-App for Improving Depressive Symptoms
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
- Being tested
- Syrenity App
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syrenity AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 6 weeks
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, investigators 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."
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Why it stopped: Study suspended for funding-related reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Syra Health
- Responsible party
- Principal investigator, Lorenzo Lorenzo-Luaces, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408025
- Sponsor's protocol ID
- 22283
- Other IDs
- 2023-0410
- Acronym
- SYRA
- Status last verified
- Jun 2026
- First submitted
- 6 May 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health-App for Improving Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06408025
- Acronym / sponsor ID
- SYRA / 22283
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended for funding-related reasons
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Syra Health
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syrenity App | Experimental | Other: Syrenity AppThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PHQ-9 >= 10
- Use an iPhone or Android
- Residing in the United States
Key exclusion criteria (1 listed)
- PHQ-9 item 9 >= 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syrenity AppCurrently, 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. | Other | Syrenity App |
Primary outcome
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.
2 secondary outcomes
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: 6 weeks
Systems Usability Scale (SUS)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syrenity App in people with Depressive Symptoms, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ-9) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.