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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451549
Other study ID # NU-015775
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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