Clinical trial NCT06568081: SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study
Official title: SloMo2: a Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Affective Psychoses
Keywords: Digital health
User-centred design
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: Sussex Partnership NHS Foundation Trust
name: Northumberland, Tyne and Wear NHS Foundation Trust
First posted: 2024-08-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and post therapy 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- and post-delivery of SloMoR2, and a 6-month follow-up for health economics data collection. 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 demographics, adverse events, and service use). 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 24 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 - 21) 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 - 21) An evaluation will be conducted to establish the effectiveness and cost-effectiveness of SloMoR2 when delivered in routine care.

3. Analysis, resource development and dissemination (month 22 - 24) Findings will be summarised in consultation with our LEAP group. They will be written up in a plain English summary and as articles for submission to peer-review publications. Experiences of therapy delivery will inform any further refinements to the SloMoR2 software. Findings will also be used to support the co-design of an automated e-learning programme for therapists and develop a commercialisation strategy to assist being scaled up in the NHS.

SAMPLE AND RECRUITMENT Service user recruitment: The recruitment target is to deliver SloMo to 150 service user participants (across Stage 1 and 2) who are: Aged ≥18 years, meet criteria for ICD-10 psychosis diagnoses (F20-29, F30-39), seeking therapy for paranoia, in contact with secondary care mental health services, and capable of providing informed consent to engage in therapy. People will be excluded if they: are at acute risk of harm to self or others, are unable to engage in therapy due to language barriers, and have a primary diagnosis of alcohol/substance dependence, learning disability, or organic brain injury or illness implicated in psychosis.

Therapist recruitment, training, and supervision: In Stage 1, an initial cohort of therapists ('high intensity'; n = 5 per trust) will be selected from senior clinicians experienced in delivery and supervision of CBT for psychosis. Therapists will be required to complete a 1-day training. They will subsequently be able to access on-demand clinical and technical supervision from their local study team as required to support SloMoR2 delivery. In Stage 2, a further 45 'high' and 'low' intensity therapists will be trained across the 3 sites. This will be based on a 'training the trainers' model. The initial cohort of five trained high intensity therapists from Stage 1 will support training and supervision of an additional 15 therapists per site. Training will be extended to 3 days for low intensity therapists. The local study team will liaise with local services to promote SloMo2 and support trainers to roll out training to other high and low intensity therapists.

Stakeholder recruitment: The experience of SloMo's delivery will be evaluated using subgroups of the therapist and participant samples recruited in Stages 1 and 2 (N = 60, and N = 150, respectively). This will involve interviewing subgroups of service users (n = 20) and therapists (n = 6) involved in SloMo's delivery, as well as senior managers (n = 5) and payers (stakeholders involved in the commissioning of mental health services; n = 5), about their experience of SloMo. The service users will be recruited by the local study team. They will approach participants who consented to be contacted about further SloMo studies, once the participant has disengaged (therapist defined) or completed therapy. The four samples will be recruited to ensure a diverse range with respect to age, ethnicity, gender, site, and professional background (for staff interviews). All potential participants will be provided with a participant information sheet and given the opportunity to ask questions before signing the consent form.

PROCEDURE The local study team will initially conduct PPI consultation with their trust therapy workforce to scope readiness for adoption of SloMoR2. This work will identify implementation barriers and facilitators, to enable tailoring of implementation resources and strategies to site needs.

Trained therapists will identify potential participants and offer them SloMo, based on their clinical judgement. Following an initial introduction, participants will provide informed consent to receive SloMo and for their data to be collected for research purposes, with an optional opt-in for contact about further SloMo research. The burden of the informed consent process will be minimised where possible. This has been done by embedding the participant information sheet and consent form at the beginning of the SloMo webapp ('therapy platform'). Therapists will review this with potential participants and address any questions they have. Data storage and strategies for data protection will be emphasised, based on PPI feedback that this is a key area of concern. It will also be emphasised that service users will be free to withdraw their consent to engage in therapy at any time or to request that their data be deleted from the SloMo software or omitted from the research analysis.

If willing to proceed, participants' consent will be provided by indicating consent on the form. Participants will not sign the consent form with their name, to minimise the personally identifiable information stored in the software. Therapists will countersign and date the consent form. A copy of the countersigned consent form will be posted or sent electronically to the participant by the local SloMo team.

Pre and post therapy measures will be collected through the SloMo therapy platform at the first (R-GPTS (part B), short WEMWBS), second (GBO) and last therapy session (all). Sessional measures will be taken at each session. The local study team will extract demographic, adverse event, and service use data from participants' medical record.

INTERVENTION SloMoR2 consists of up to 11 digitally supported therapy platform modules targeting paranoia and a mobile app for use outside of sessions. Therapy will be delivered according to the SloMo manual instructions for use. The therapy helps people learn to slow down for a moment to find ways of feeling safer and living well. Animated stories and interactive tasks support participants to learn how to apply SloMo tips to manage their worries, with in-session content synchronised to the mobile app which provides out of session support.

OUTCOMES

1a) Implementation To address the primary research question, is SloMoR2 implementable in routine care, quantitative data will be gathered for the following primary outcomes: i) safety, measured by frequency of any unanticipated serious therapy and/or device-related adverse events, and ii) service user engagement, measured by the proportion of participants who are delivered 5 or more SloMo sessions ('minimum therapeutic dose'). In addition, data will be gathered for the following secondary outcomes: i) service user engagement, measured by the number of individuals who begin (1 or more sessions) and complete therapy (8 or more sessions, 'full course' as three modules are optional), ii) therapist uptake, measured by the percentage of therapists that receive SloMo R2 training who commence therapy with at least one participant, iii) adherence, measured by percentage completion of sessions started, iv) usage, service user usage of mobile app, v) acceptability, measured by the percentage of positive responses on the NHS Family and Friends Test, vi) fidelity, competence of therapy delivery (with a random selection of 10 sessions per site assessed by the local study lead), vii) stakeholder experience of implementation, based on qualitative interviews with service users, therapists, senior managers, and payers, and viii) usability, measured by the User Experience Survey (UES; Service user and therapist). The qualitative interviews exploring user experience in participants who have been offered SloMo will be lived experience researcher-led. The qualitative interviews with therapists will explore experiences of training and delivery of SloMoR2 in more detail. Finally, senior managers and payers, who have and have not been involved in implementing SloMo, will be interviewed to understand their perspective on SloMo and its scale-up. All interviews will be audio recorded and transcribed for analysis. Participants will be reimbursed for their time according to INVOLVE guidelines.

1b) Effectiveness To address the primary research question, is SloMoR2 effective for paranoia and wellbeing when delivered in routine care, participants will complete (via the SloMo therapy platform) three brief questionnaires at the beginning and end of therapy. The primary effectiveness outcome measure is the persecution subscale (part B) of the Revised Green Paranoid Thoughts Scale (RGPTS-B). Secondary effectiveness outcome measures are the short Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and the Goal Based Outcome. Sessional measures will be collected during therapy sessions to monitor progress, using four scales (rated from 0 - 100) of paranoia distress, fast and slow thinking, safety beliefs and confidence.

1b) Cost-effectiveness To address the primary research question, is SloMoR2 cost-effective when delivered in routine care, costs and savings will be evaluated by the local study team extracting mental health service use data from participant medical records using the Client Service Receipt Inventory (CSRI), and QALYs derived from an algorithm applied to the Revised Green Paranoid Thoughts Scale, persecution subscale (part B) (RGPTS-B). Mental health service use data will cover the 6-month period prior to the intervention, the period during the intervention, and the 6-month period following its end. This analysis will also incorporate the service use data collected for the SlowMoR1 trial as this will provide additional data to enhance the health economic modelling.

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

Primary outcomes:
measure: Implementation: Safety (adverse event incidence)
timeFrame: Pre-therapy to 6 months post therapy discharge.
measure: Implementation: Service user engagement
timeFrame: Duration of therapy (up to 6 months)
measure: Effectiveness: Paranoid thoughts
timeFrame: Pre- to post-therapy.
measure: Cost-effectiveness: Service use
timeFrame: Pre-therapy to 6 months post therapy discharge.
measure: Cost-effectiveness: Paranoid thoughts
timeFrame: Pre-therapy to 6 months post therapy discharge.
Secondary outcomes:
measure: Implementation: Service user engagement
timeFrame: Duration of therapy (up to 6 months)
measure: Implementation: Therapist uptake
timeFrame: Duration of study (24 months)
measure: Implementation: Adherence
timeFrame: Duration of therapy (up to 6 months)
measure: Implementation: Usage
timeFrame: Pre- to post-therapy (up to 6 months)
measure: Implementation: Acceptability
timeFrame: Post-therapy (at up to 6 months)
measure: Implementation: Fidelity
timeFrame: Duration of study (24 months)
measure: Implementation: Stakeholder experience of implementation
timeFrame: Duration of study (24 months)
measure: Implementation: Usability
timeFrame: Post-therapy (at up to 6 months)
measure: Effectiveness: Wellbeing
timeFrame: Pre- to post-therapy (up to 6 months)
measure: Effectiveness: Sessional measures
timeFrame: Duration of therapy (up to 6 months)
measure: Effectiveness: Goal attainment
timeFrame: Pre- to post-therapy (up to 6 months)
measure: Cost-effectiveness: Wellbeing
timeFrame: Pre- to 6 months post-therapy.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Amy Hardy
role: PRINCIPAL_INVESTIGATOR
References: