RecruitingNot ApplicableNCT06568081

SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study

SloMo2: A Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care


Sponsor

King's College London

Enrollment

150 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Worries about harm from others (also known as paranoia) are common. Thinking fast or going on gut feelings is natural but can fuel these worries. For some, fast thinking and worries start to get in the way of life. Cognitive behaviour therapy for psychosis (CBTp) is the recommended talking therapy. However, only a minority of people can access CBTp due to limited resources, and even when available, therapy can be difficult to do and use in daily life. SloMo is a digitally supported therapy that aims to overcome these barriers, and was developed by people with psychosis, designers, and psychologists. It supports people to notice worries and fast thinking habits. During therapy sessions, people learn to slow down and feel safer. Personalised spinning thought bubbles are slowed down using SloMo tips. An app provides access to helpful messages. SloMo was previously tested in a randomised trial of 361 people attending mental health services. SloMo was found to be safe to use, with no adverse events linked to the software. People in the SloMo group had lower paranoia, and better confidence and wellbeing, over 6 months compared to people who just received their usual care. People found SloMo enjoyable and easy to use. The next step is to evaluate if SloMo can be safely and effectively delivered by therapists working in NHS services. If SloMo works in routine care, the therapy will be made more widely available in the NHS. An improved version of SloMo has been co-produced based on feedback. Sixty therapists will be trained and supervised in 3 trusts to deliver SloMo to 150 people who fear harm from others. Safety, technical performance, uptake, engagement and acceptability data, alongside interviews with patients, therapists, and managers, will investigate how SloMo is used. Paranoia severity and wellbeing will be measured pre, post therapy, and at 12 months follow up, to find out if SloMo helps. Service use data will evaluate costs and savings.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Meet criteria for ICD-10 psychosis diagnoses (F20-29, F30-39)
  • Seeking therapy for paranoia
  • In contact with secondary care mental health services
  • Capacity to provide informed consent to engage in therapy

Exclusion Criteria3

  • Acute risk of harm to self or others
  • Unable to engage in therapy due to language barriers
  • Primary diagnosis of alcohol/substance dependence, learning disability, or organic brain injury or illness implicated in psychosis

Interventions

OTHERSloMo

SloMo, is a blended digital therapeutic for people who fear harm from others. It is based on cognitive-behavioural therapy for psychosis. An online therapy platform supports the delivery of 11 face-to-face modules, which are synchronised to a native mobile app for use in daily life. SloMo works by helping people to notice their worries and fast thinking habits, and encourages them to slow down for a moment to find ways of feeling safer.


Locations(1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

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NCT06568081


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