Clinical trial NCT06451549: Clinical Investigation of Syndi
Official title: Real-world Evaluation of a Recommender System for Mental Health Self-management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Health Issue
Depression
Anxiety
Keywords: Digital Health
Recommender System
Mental Health
Telemedicine
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Cornwall Partnership NHS Foundation Trust
name: University of Plymouth
First posted: 2024-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be given access to Syndi immediately
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression Severity
timeFrame: 2 weeks and 3 months post-baseline
Secondary outcomes:
measure: Anxiety Severity
timeFrame: 2 weeks and 3 months post-baseline
measure: Mental Wellbeing
timeFrame: 2 weeks and 3 months post-baseline
measure: Functional Impairment
timeFrame: 2 weeks and 3 months post-baseline
measure: Engagement with recommended apps
timeFrame: 2 weeks post-baseline
measure: User experience with the Syndi recommender system
timeFrame: Immediately after app recommendations and at 2 weeks post-baseline
measure: User perceptions of the system
timeFrame: Semi-structured interview call, 2 months after start of the trial
measure: User perceptions of the recommended apps
timeFrame: Semi-structured interview call, 2 months after start of the trial
Other outcomes:
Locations:
city: Ashton under Lyne
country: United Kingdom
facility: Pennine Care NHS Foundation Trust
state: Lancashire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle University
state: Tyne and Wear
city: Bodmin
country: United Kingdom
facility: Cornwall Partnership NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Devon Partnership NHS Trust
Study officials:
affiliation: University of Plymouth
name: Rohit Shankar, FRPsych
role: PRINCIPAL_INVESTIGATOR
References: