Clinical Investigation of Syndi

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Anxiety; Mental Health Issue
• Intervention / Treatment: Device: Syndi recommender system for mental health apps

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bodmin, United Kingdom, PL31 2QN
    • Cornwall Partnership NHS Foundation Trust
  • Exeter, United Kingdom, EX2 5AF
    • Devon Partnership NHS Trust
  • Lancashire
    • Ashton under Lyne, Lancashire, United Kingdom, OL6 7SR
      • Pennine Care Nhs Foundation Trust
  • Tyne and Wear
    • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
      • Newcastle University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Syndi recommender system for mental health apps; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
User perceptions of the system	Qualitative feedback from semi-structured interviews about Syndi	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	Semi-structured interview call, 2 months after start of the trial

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: University of Plymouth; Cornwall Partnership NHS Foundation Trust
• Investigators: Principal Investigator: Rohit Shankar, FRPsych, University of Plymouth

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Mental Health; Digital Health; Recommender System
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NU-015775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the Academic CIs and their research staff will have access to research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No