Outputs (3)

Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide (2024)
Journal Article
Taher, R., Hall, C. L., Gomez Bergin, A. D., Gupta, N., Heaysman, C., Jacobsen, P., Kabir, T., Kalnad, N., Keppens, J., Hsu, C.-W., McGuire, P., Peters, E., Shergill, S., Stahl, D., Wensley Stock, B., & Yiend, J. (2024). Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide. Trials, 25, Article 604. https://doi.org/10.1186/s13063-024-08421-1

Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, inc... Read More about Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide.

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context (2024)
Journal Article
Taher, R., Bhanushali, P., Allan, S., Alvarez-Jimenez, M., Bolton, H., Dennison, L., Wallace, B. E., Hadjistavropoulos, H. D., Hall, C. L., Hardy, A., Henry, A. L., Lane, S., Maguire, T., Moreton, A., Moukhtarian, T. R., Perez Vallejos, E., Shergill, S., Stahl, D., Thew, G. R., Timulak, L., …Yiend, J. (2024). Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context. BJPsych Open, 10(4), Article e126. https://doi.org/10.1192/bjo.2024.713

Background
Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed fo... Read More about Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.

Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial (2023)
Preprint / Working Paper
Khan, K., Hall, C. L., Babbage, C., Dodzo, S., Greenhalgh, C., Lucassen, M., Merry, S., Sayal, K., Sprange, K., Stasiak, K., Tench, C. R., Townsend, E., Stallard, P., & Hollis, C. Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial

Background:

A serious game (SPARX), developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression. Howev... Read More about Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial.