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NCT06568081Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

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. At least sixty therapists will be trained and supervised in 3 trusts to deliver SloMo to at least 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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
13 Aug 2024
Start date
16 Oct 2024
Primary completion date
Sept 2027
Lead sponsor
King's College London
NCT number
NCT06568081

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 16 Oct 2024 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unable to engage in therapy due to language barriers

Other illness

  • Primary diagnosis of alcohol/substance dependence, learning disability, or organic brain injury or illness implicated in psychosis

Other

  • Acute risk of harm to self or others

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
South London and Maudsley NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.