Thanks to IT4Anxiety, 18 start-ups were able to test their product or solution with users or mental health professionals

Innovative tools are transformative products, services, processes, or ideas that offer significant improvements over existing solutions. In the context of mental health, these tools play a vital role in addressing the needs of individuals living with anxiety-related conditions. Startups are at the forefront of innovation, often driven by a passion for creating positive change. IT4Anxiety recognizes the importance of these early-stage ventures and actively supports them through the testing phase of their tool development (intervention) in Work Package 2. In a collaborative approach across all the partners, WP2 managed the selection, development and support of twenty Startup innovative tools, of these eighteen underwent testing. .

One of the key tasks in WP2 involves working with the startups to establish a comprehensive testing protocol. This protocol serves as a framework for evaluating the safety, delivery methods, accessibility, and effectiveness of their intervention. However, it is noted that, for a number of Startups, a study protocol was not appropriate for their stage of development and type of testing. We aligned the Startup testing with partner sites as shown below.

Overview of Startup technology

We manged a diverse range of technologies including apps, EEG, ECG, virtual reality, monitoring, and tracking.

WP2 Output Metrics

The workflow of WP2 consisted of several important stages, including, protocol development, MAST review of the protocol[1], IT4 ethics review, local ethics review, and testing status. Here is a summary of the number of startups that reached each stage:

WP2 Stage

No. of Startups

Protocol developed

16

MAST review

16

IT4 ethics submission

13

Local ethics submission

15

Tested

18

Not tested (support only)

2

 

It is noted that two of the startups underwent pre-clinical testing, where no protocol was necessary during this stage and for another three startups local ethics was not required due to the nature of the testing. Furthermore the IT4 ethics submission was an optional support service that the startup could utilize if needed.

The table and graphs presented below illustrate the range of testing categorized by participant target group, clinical testing phase, and the number of participants (with a cumulative count of 741).

Comparative clinical testing phase

No. of Startups

Pre-Clinical

2

Phase 1

10

Phase 2

6

Total

18

 

[1] MAST is the Model for ASsessment of Telemedicine applications (MAST) and was first developed in 2012 in another EU project called EUnetHTA. Its purpose is to offer a systematic and multidisciplinary assessment of the impact of integrated telemedicine services. MAST can be used to decide whether or not to implement telemedicine/ehealth services in healthcare systems. In the IT4Anxiety project, the MAST evaluation framework is employed as a metric to gauge the potential effectiveness and quality of care contribution of a proposed intervention by a Startup. It is being utilized to evaluate the Startup's study protocol, allowing for the identification of areas that need improvement prior to local ethics submission.

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