Clinical Investigation of Syndi

Depression Clinical Trial

Official title:

Real-world Evaluation of a Recommender System for Mental Health Self-management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451549
• Other study ID #: NU-015775
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Newcastle University
• Contact: Edward Meinert, PhD
• Phone: 0191 208 6000
• Email: edward.meinert[@]newcastle.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health Issue

Intervention

Device:
• Syndi recommender system for mental health apps
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.

Locations

Country	Name	City	State
United Kingdom	Pennine Care NHS Foundation Trust	Ashton under Lyne	Lancashire
United Kingdom	Cornwall Partnership NHS Foundation Trust	Bodmin
United Kingdom	Devon Partnership NHS Trust	Exeter
United Kingdom	Newcastle University	Newcastle Upon Tyne	Tyne And Wear

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle University	Cornwall Partnership NHS Foundation Trust, University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Severity	Score on the Patient Health Questionnaire-9 (PHQ-9), total scores range from 0 to 27 (higher scores indicate more severe depression)	2 weeks and 3 months post-baseline
Secondary	Anxiety Severity	Score on the Generalised Anxiety Disorder-7 (GAD-7), total scores range from 0 to 21 (higher scores indicate more severe anxiety)	2 weeks and 3 months post-baseline
Secondary	Mental Wellbeing	Score on the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), total scores range from 7 to 35 (higher scores indicate better wellbeing)	2 weeks and 3 months post-baseline
Secondary	Functional Impairment	Score on the Work and Social Adjustment Scale (WSAS), total scores range from 0 to 40 (higher scores indicate higher functional impairment)	2 weeks and 3 months post-baseline
Secondary	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)	2 weeks post-baseline
Secondary	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)	Immediately after app recommendations and at 2 weeks post-baseline
Secondary	User perceptions of the system	Qualitative feedback from semi-structured interviews about Syndi	Semi-structured interview call, 2 months after start of the trial
Secondary	User perceptions of the recommended apps	Qualitative feedback from semi-structured interviews about the apps recommended by Syndi	Semi-structured interview call, 2 months after start of the trial