SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study

NCT06568081 | Recruiting

• 1 other identifier: 338439
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Affective Psychoses

Keywords

Digital health; User-centred design

Outcome Measures

Primary Outcomes (5)

• Implementation: Safety (adverse event incidence)

  Frequency of any unanticipated serious therapy and/or device-related adverse events

  Pre-therapy to post-therapy.

• Implementation: Service user engagement

  Proportion of participants who are delivered 5 or more SloMo sessions ('minimum therapeutic dose')

  Duration of therapy (typically up to 6 months)

• Effectiveness: Paranoid thoughts

  Revised Green Paranoid Thoughts Scale, persecution subscale (part B) (RGPTS-B, Freeman et al, 2021). Range 0-40, higher scores indicate worse outcome.

  Pre- to post-therapy.

• Cost-effectiveness: Service use

  Unit costs calculated from the Client Service Receipt Inventory (CSRI, Beecham and Knapp, 2001)

  Pre-therapy to post-therapy.

• Cost-effectiveness: Paranoid thoughts

  QALYs derived from an algorithm applied to the Revised Green Paranoid Thoughts Scale, persecution subscale (part B) (RGPTS-B, Freeman et al, 2021)

  Pre-therapy to post-therapy.

Secondary Outcomes (20)

• Implementation: Service user engagement

  Duration of therapy (typically up to 6 months)

• Implementation: Therapist uptake

  Duration of study (42 months)

• Implementation: Adherence

  Duration of therapy (typically up to 6 months)

• Implementation: Usage

  Pre- to post-therapy (typically up to 6 months)

• Implementation: Acceptability

  Post-therapy (typically up to 6 months)

Study Arms (1)

SloMo

EXPERIMENTAL

Other: SloMo

Interventions

SloMo OTHER

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.

SloMo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator
• Sussex Partnership NHS Foundation Trust: collaborator
• Northumberland, Tyne and Wear NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Amy Hardy

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn M Taylor

CONTACT

07876876164; kathryn.taylor@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 23, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be made available after completion of data collection and analysis, and publication of the main outcome papers, and will be available indefinitely via CSDR.
• Access Criteria: CSDR provides an ongoing forum where research proposals are checked and reviewed in 3 stages: 1) by the Wellcome Trust, which is the secretariat for the Independent Review Panel (IRP), 2) study funders sponsors and 3) the IRP. Direct requests for access must be accompanied by a protocol setting out the aims of the study for which the data are requested, very brief details of the credentials of team conducting the study (institutional affiliation, degrees or qualifications), methods outlined and appropriate ethical approval in place.

Locations

GB (1)