NCT06568081 SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study
| NCT ID | NCT06568081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Schizophrenia Spectrum and Other Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-10-16 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Amy Hardy
PRINCIPAL INVESTIGATOR
King's College London
Frequently Asked Questions
Who can join the NCT06568081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia Spectrum and Other Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568081 currently recruiting?
Yes, NCT06568081 is actively recruiting participants. Contact the research team at kathryn.taylor@kcl.ac.uk for enrollment information.
Where is the NCT06568081 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06568081 clinical trial?
NCT06568081 is sponsored by King's College London. The principal investigator is Amy Hardy at King's College London. The trial plans to enroll 150 participants.
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