Clinical Investigation of Syndi

NCT06451549 | Withdrawn

• 1 other identifier: NU-015775
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Mental Health Issue; Depression; Anxiety

Keywords

Digital Health; Recommender System; Mental Health; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Anxiety Severity

  2 weeks and 3 months post-baseline

• Mental Wellbeing

  2 weeks and 3 months post-baseline

• Functional Impairment

  2 weeks and 3 months post-baseline

• Engagement with recommended apps

  2 weeks post-baseline

• User experience with the Syndi recommender system

  Immediately after app recommendations and at 2 weeks post-baseline

Study Arms (1)

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.

Device: Syndi recommender system for mental health apps

Interventions

Syndi recommender system for mental health apps DEVICE

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.

Syndi recommender system for mental health apps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle University: lead
• Cornwall Partnership NHS Foundation Trust: collaborator
• University of Plymouth: collaborator

Study Sites (4)

Pennine Care NHS Foundation Trust

Ashton-under-Lyne, Lancashire, OL6 7SR, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

Location

Cornwall Partnership NHS Foundation Trust

Bodmin, PL31 2QN, United Kingdom

Location

Devon Partnership NHS Trust

Exeter, EX2 5AF, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Rohit Shankar, FRPsych

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As this is a single arm study, all participants will receive the intervention and no masking is required.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Digital Health and Clinical Artificial Intelligence

Model Details: All participants will be given access to Syndi immediately

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)