Digital therapy for managing paranoia in psychosis
SloMo2: A Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care
This study is testing a new digital therapy to help people with schizophrenia and other psychotic disorders manage paranoia and racing thoughts in their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06568081 on ClinicalTrials.gov |
What this trial studies
This study evaluates the implementation and effectiveness of SloMoR2, a digitally supported therapy designed to help individuals with schizophrenia and other psychotic disorders manage paranoia and fast thinking. The therapy, developed collaboratively with input from those with lived experience, therapists, and designers, aims to make cognitive behavioral therapy more accessible and practical in everyday life. Participants will receive therapy from both high and low intensity therapists, and outcomes will be assessed through questionnaires, software analytics, and interviews over a 24-month period. The study will take place across three NHS trusts in the UK.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with psychosis who are seeking therapy for paranoia and are in contact with secondary care mental health services.
Not a fit: Patients who are at acute risk of harm to themselves or others, or those with primary diagnoses of substance dependence or learning disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients experiencing paranoia by providing them with effective coping strategies.
How similar studies have performed: Previous studies have shown that digitally supported therapies can be effective, suggesting a promising avenue for this approach, although SloMo itself is a novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- South London and Maudsley NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Amy Hardy — King's College London
- Study coordinator: Kathryn M Taylor
- Email: kathryn.taylor@kcl.ac.uk
- Phone: 07876876164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.