Mental Health IssueNCT06451549
Clinical Investigation of Syndi
A study testing Syndi recommender system for mental health apps in people with Mental Health Issue and Depression, run by Newcastle University at 4 sites in United Kingdom.
Trial summary
Mental health concerns are a growing global concern, but support can still be difficult to access. Digital health technologies can help people access support, but with over 10,000 mental health apps available, it can be difficult to choose one that is safe, effective, and personalised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue, Depression, Anxiety
- What is being tested?
- Syndi recommender system for mental health apps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Aug 2024to Nov 2024
- 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
- Based in the UK
- Referred or self-referred to proceed through the standard NHS Talking Therapies care pathway OR people with mental health concerns looking for app recommendations online;
- Willing and able to provide informed consent;
- Aged 18 years or older;
- Able to speak English;
- Have access to the internet and own a smartphone.
Who cannot join
- Patients with a PHQ-9 score >=20
- Patients with suicidal ideation measured as an answer of 'YES' to any question in the Columbia Suicide Severity Rating Scale (C-SSRS);
- Incapable of self-consent;
- In a dependent/unequal relationship with the research or care teams or any PPI representatives.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Pennine Care NHS Foundation Trust
Ashton-under-Lyne, Lancashire, OL6 7SR
Cornwall Partnership NHS Foundation Trust
Bodmin, PL31 2QN
Devon Partnership NHS Trust
Exeter, EX2 5AF
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
About this study
Official title: Real-world Evaluation of a Recommender System for Mental Health Self-management
Mental health concerns are a growing global concern, but support can still be difficult to access. Digital health technologies can help people access support, but with over 10,000 mental health apps available, it can be difficult to choose one that is safe, effective, and personalised. Syndi is a digital health platform that uses a machine learning system to provide personalised recommendations of mental health apps. This study aims to examine the impact of Syndi and its recommendations on the mental health and well-being of people with mental health concerns.
The investigators will use the standard National Health Service (NHS) Talking Therapies measures of anxiety and depression, as well as additional measures of wellbeing and functional impairment to look at the impact of Syndi on patients' mental well-being. The investigators will also look at user experience with Syndi using a survey. Users' engagement with Syndi and its recommended apps will be assessed using a short survey and some participants will be randomly selected for an interview so the investigators can get a better understanding of what people liked and disliked about using the platform and why.
The investigators expect that the project will show that using Syndi helps improve mental well-being in people with mental health concerns. If the study shows this positive impact, this will provide evidence to support the use of Syndi to improve the accessibility of mental health support in clinical pathways. The investigators will publish the results of the study in academic journals as well as in more accessible platforms.
- Conditions
- Mental Health Issue, Depression, Anxiety
- Being tested
- Syndi recommender system for mental health apps
- Keywords
- Digital Health, Recommender System, Mental Health, Telemedicine
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndi recommender system for mental health appsDevice
Syndi is a mental health app recommendation system. It provides personalised suggestions of apps to help users self-manage their mental health based on a clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| Syndi recommender system for mental health apps | Experimental | Syndi is a recommender system for mental health apps, delivered via a website. It guides users through a clinically-validated self-assessment and uses a machine learning system to provide personalised recommendations of independently-rated mental health tools. Receives: Device: Syndi recommender system for mental health apps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity
Score on the Patient Health Questionnaire-9 (PHQ-9), total scores range from 0 to 27 (higher scores indicate more severe depression)
Measured: 2 weeks and 3 months post-baseline
Secondary outcomes (7)
Anxiety Severity
Score on the Generalised Anxiety Disorder-7 (GAD-7), total scores range from 0 to 21 (higher scores indicate more severe anxiety)
Measured: 2 weeks and 3 months post-baseline
Mental Wellbeing
Score on the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), total scores range from 7 to 35 (higher scores indicate better wellbeing)
Measured: 2 weeks and 3 months post-baseline
Functional Impairment
Score on the Work and Social Adjustment Scale (WSAS), total scores range from 0 to 40 (higher scores indicate higher functional impairment)
Measured: 2 weeks and 3 months post-baseline
Engagement with recommended apps
Self-report questionnaire about engagement with recommended apps (subjective, with questions about which apps were downloaded, how long they used it for, and how useful they found the app)
Measured: 2 weeks post-baseline
User experience with the Syndi recommender system
Score on a user experience questionnaire. Items were assessed individually on a scale from 1-5, with higher scores indicating better experience (negative items were reverse coded)
Measured: Immediately after app recommendations and at 2 weeks post-baseline
User perceptions of the system
Qualitative feedback from semi-structured interviews about Syndi
Measured: Semi-structured interview call, 2 months after start of the trial
User perceptions of the recommended apps
Qualitative feedback from semi-structured interviews about the apps recommended by Syndi
Measured: Semi-structured interview call, 2 months after start of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: The study has been withdrawn due to significant changes in its scope, which no longer align with the original protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be given access to Syndi immediately
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornwall Partnership NHS Foundation Trust, University of Plymouth
- Responsible party
- Principal investigator, Edward Meinert, Newcastle University
- Investigators
- Rohit Shankar, FRPsych, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451549
- Sponsor's protocol ID
- NU-015775
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the Academic CIs and their research staff will have access to research data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of a Recommender System for Mental Health Self-management
- ClinicalTrials.gov ID
- NCT06451549
- Acronym / sponsor ID
- NU-015775
- Conditions
- Mental Health Issue, Depression, Anxiety
- Keywords
- Digital Health, Recommender System, Mental Health, Telemedicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn due to significant changes in its scope, which no longer align with the original protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Cornwall Partnership NHS Foundation Trust, University of Plymouth
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 11 Jun 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.
Mental health concerns are a growing global concern, but support can still be difficult to access. Digital health technologies can help people access support, but with over 10,000 mental health apps available, it can be difficult to choose one that is safe, effective, and personalised. Syndi is a digital health platform that uses a machine learning system to provide personalised recommendations of mental health apps. This study aims to examine the impact of Syndi and its recommendations on the mental health and well-being of people with mental health concerns.
The investigators will use the standard National Health Service (NHS) Talking Therapies measures of anxiety and depression, as well as additional measures of wellbeing and functional impairment to look at the impact of Syndi on patients' mental well-being. The investigators will also look at user experience with Syndi using a survey. Users' engagement with Syndi and its recommended apps will be assessed using a short survey and some participants will be randomly selected for an interview so the investigators can get a better understanding of what people liked and disliked about using the platform and why.
The investigators expect that the project will show that using Syndi helps improve mental well-being in people with mental health concerns. If the study shows this positive impact, this will provide evidence to support the use of Syndi to improve the accessibility of mental health support in clinical pathways. The investigators will publish the results of the study in academic journals as well as in more accessible platforms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be given access to Syndi immediately
| Arm | Type | Receives |
|---|---|---|
| Syndi recommender system for mental health apps | Experimental | Device: Syndi recommender system for mental health appsSyndi is a recommender system for mental health apps, delivered via a website. It guides users through a clinically-validated self-assessment and uses a machine learning system to provide personalised recommendations of independently-rated mental health tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Based in the UK
- Referred or self-referred to proceed through the standard NHS Talking Therapies care pathway OR people with mental health concerns looking for app recommendations online;
- Willing and able to provide informed consent;
- Aged 18 years or older;
- Able to speak English;
Key exclusion criteria (4 listed)
- Patients with a PHQ-9 score >=20
- Patients with suicidal ideation measured as an answer of 'YES' to any question in the Columbia Suicide Severity Rating Scale (C-SSRS);
- Incapable of self-consent;
- In a dependent/unequal relationship with the research or care teams or any PPI representatives.
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 |
|---|---|---|
| Syndi recommender system for mental health appsSyndi is a mental health app recommendation system. It provides personalised suggestions of apps to help users self-manage their mental health based on a clinical assessment. | Device | Syndi recommender system for mental health apps |
Primary outcome
Depression Severity
Time frame: 2 weeks and 3 months post-baseline
Score on the Patient Health Questionnaire-9 (PHQ-9), total scores range from 0 to 27 (higher scores indicate more severe depression)
7 secondary outcomes
Anxiety Severity
Time frame: 2 weeks and 3 months post-baseline
Mental Wellbeing
Time frame: 2 weeks and 3 months post-baseline
Functional Impairment
Time frame: 2 weeks and 3 months post-baseline
Engagement with recommended apps
Time frame: 2 weeks post-baseline
User experience with the Syndi recommender system
Time frame: Immediately after app recommendations and at 2 weeks post-baseline
User perceptions of the system
Time frame: Semi-structured interview call, 2 months after start of the trial
User perceptions of the recommended apps
Time frame: Semi-structured interview call, 2 months after start of the trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No. Only the Academic CIs and their research staff will have access to research data.
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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.
Rohit Shankar, FRPsych principal investigator
University of Plymouth
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syndi recommender system for mental health apps in people with Mental Health Issue and Depression, run by Newcastle University at 4 sites in United Kingdom.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depression Severity (time frame: 2 weeks and 3 months post-baseline). 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 6 Feb 2025.