SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study
NCT Number: NCT06568081
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders|Affective Psychoses
Interventions: OTHER: SloMo
Sponsor: King's College London
Collaborators: South London and Maudsley NHS Foundation Trust|Sussex Partnership NHS Foundation Trust|Cumbria, Northumberland Tyne and Wear NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01

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 and post therapy to find out if SloMo helps. Service use data will evaluate costs and savings.

Primary Outcome Measures: Implementation: Safety (adverse event incidence), Frequency of any unanticipated serious therapy and/or device-related adverse events, Pre-therapy to 6 months post therapy discharge.|Implementation: Service user engagement, Proportion of participants who are delivered 5 or more SloMo sessions ('minimum therapeutic dose'), Duration of therapy (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 6 months post therapy discharge.|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 6 months post therapy discharge.
Secondary Outcome Measures: Implementation: Service user engagement, Number of individuals who begin (1 or more sessions) and complete therapy (8 or more sessions, 'full course' as three modules are optional), Duration of therapy (up to 6 months)|Implementation: Therapist uptake, Percentage of therapists that receive SloMo R2 training who commence therapy with at least one participant, Duration of study (24 months)|Implementation: Adherence, Percentage completion of sessions started., Duration of therapy (up to 6 months)|Implementation: Usage, Percentage of service users meeting mobile app adherence criteria (at least 1 home screen interaction after a minimum of 3 therapy sessions)., Pre- to post-therapy (up to 6 months)|Implementation: Acceptability, Percentage of positive responses on the NHS Family and Friends Test, Post-therapy (at up to 6 months)|Implementation: Fidelity, Proportion of therapists meeting competence on the Revised Cognitive Therapy Scale (CTS-R) (of a random selection of 10 sessions scored per site, assessed by the local study lead)., Duration of study (24 months)|Implementation: Stakeholder experience of implementation, Qualitative interviews with i) service users, ii) therapists, iii) senior managers, iv) payers, Duration of study (24 months)|Implementation: Usability, User Experience Survey (UES, Hardy et al, 2022; Service user and therapist), Post-therapy (at up to 6 months)|Effectiveness: Wellbeing, Short-Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Stewart-Brown et al, 2009). Range 7-35, higher scores indicate better outcome., Pre- to post-therapy (up to 6 months)|Effectiveness: Sessional measures, Collected using visual analogue scales (rated from 0 - 100) of paranoia distress, fast and slow thinking, safety beliefs and confidence, Duration of therapy (up to 6 months)|Effectiveness: Goal attainment, Goal Based Outcome (GBO, Law et al, 2015). Range 0 (no progress) to 10 (goal has been reached), higher scores indicate better outcome., Pre- to post-therapy (up to 6 months)|Cost-effectiveness: Wellbeing, QALYs derived from an algorithm applied to the Short-Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Stewart-Brown et al, 2009), Pre- to 6 months post-therapy.