SloMo2: A Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- King's College London
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Effectiveness: Paranoid thoughts
Study Overview
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. 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.
Detailed Description
DESIGN AND AIMS The study is a repeated measures design, with clinical outcome assessments pre-, post-delivery of SloMoR2, and a 12-month follow-up. The aim is to evaluate if SloMo is implementable and effective when delivered in routine care by therapists working in NHS routine services. Delivery with high and low intensity therapists will be evaluated, with the former holding doctorate or diploma therapy qualifications, and the latter representing graduate psychologists or the NHS's expanding workforce of psychological practitioners. Outcomes will be evaluated using questionnaires, software analytics, and medical record data (for adverse events, service use, and demographics when not self-reported). Interviews will be conducted with a subgroup of relevant stakeholders to understand their experiences of SloMo.
The project will be conducted in 3 NHS trusts. Each trust will have a local study team, funded by the research grant and directly employed by local services, to support training, supervision, and implementation. Design research has already been conducted in preparation for the study to support the co-production of an improved version of SloMo tailored for implementation (SloMoR2). The study will run for 42 months and consists of four stages:
1. Site set-up (month 1-3) Site set-up will be conducted to pilot the training, supervision, and technical support procedures that will ensure SloMoR2's performance, data protection and clinical safety.
2a. Process evaluation: Implementation (month 4 - 39) A mixed-method process evaluation will be co-produced to understand how SloMoR2 is experienced, including safety, engagement, adherence, acceptability, fidelity & usability, and to identify barriers and enablers to implementation.
2ba. Effectiveness and cost-effectiveness (month 4 - 39) An evaluation will be conducted to establish the effectiveness and cost-effectiveness of SloMoR2 when delivered in routine care, including 12 month follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SloMo
Intervention: SloMo (Other)
Outcomes
Primary Outcomes
Effectiveness: Paranoid thoughts
Time Frame: Pre- to post-therapy.
Revised Green Paranoid Thoughts Scale, persecution subscale (part B) (RGPTS-B, Freeman et al, 2021). Range 0-40, higher scores indicate worse outcome.
Implementation: Safety (adverse event incidence)
Time Frame: Pre-therapy to post-therapy.
Frequency of any unanticipated serious therapy and/or device-related adverse events
Implementation: Service user engagement
Time Frame: Duration of therapy (typically up to 6 months)
Proportion of participants who are delivered 5 or more SloMo sessions ('minimum therapeutic dose')
Cost-effectiveness: Service use
Time Frame: Pre-therapy to post-therapy.
Unit costs calculated from the Client Service Receipt Inventory (CSRI, Beecham and Knapp, 2001)
Cost-effectiveness: Paranoid thoughts
Time Frame: Pre-therapy to post-therapy.
QALYs derived from an algorithm applied to the Revised Green Paranoid Thoughts Scale, persecution subscale (part B) (RGPTS-B, Freeman et al, 2021)
Secondary Outcomes
- Cost-effectiveness: Wellbeing(Pre- to 6 months post-therapy.)
- 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))
- Implementation: Fidelity(Duration of study (42 months))
- Effectiveness: Paranoid thoughts - follow-up(Pre-therapy to 12 months follow-up)
- Cost-effectiveness: Paranoid thoughts - follow-up(Pre-therapy to 12 months follow-up.)
- Cost-effectiveness: Service use - follow-up(Pre-therapy to 12 months follow-up.)
- Implementation: Safety (adverse event incidence) - follow-up(Pre-therapy to 12 months follow-up)
- Implementation: Stakeholder experience of implementation(Duration of study (42 months))
- Implementation: Usability(Post-therapy (typically up to 6 months))
- Effectiveness: Wellbeing(Pre- to post-therapy (typically up to 6 months))
- Effectiveness: Sessional measures(Duration of therapy (typically up to 6 months))
- Effectiveness: Goal attainment(Pre- to post-therapy (typically up to 6 months))
- Effectiveness: Wellbeing - follow-up(Pre-therapy to 12 months follow-up)
- Effectiveness: Sessional measures - follow-up(Pre-therapy to 12 month follow-up)
- Effectiveness: Goal attainment - follow-up(Pre-therapy to 12 months follow-up)
- Cost-effectiveness: Wellbeing - follow-up(Pre-therapy to 12 months follow-up.)