Care coordinator delivered method of levels therapy to improve engagement and other outcomes in early psychosis (CAMEO): a feasibility cluster randomised controlled trial
First-episode psychosis
The study uses a feasibility cluster randomised controlled trial (C-RCT) design with two parallel conditions: (1) treatment as usual (TAU) or (2) TAU plus support from a care coordinator who has received training in Method of Levels (MOL). Randomisation will take place at the level of EIP teams. Approximately 12 teams will be allocated to groups in random permuted blocks using an online randomisation service (Sealed Envelope Ltd., 2021). Because the researchers are primarily interested in the feasibility of the training programme and the use of the intervention, group allocation will be in a ratio of 1:2, with twice as many teams allocated to the intervention arm than the control arm. Future allocations will be concealed until teams are randomised. Care coordinators working in teams allocated to TAU will not receive MOL training but will continue to have access to any training and supervision normally available. Care coordinators in teams allocated to the treatment arm will receive access to a 3-day MOL training course and monthly MOL supervision sessions for the duration of the study, in addition to any training and supervision they would normally receive. To reduce contamination risk, teams will be located at separate geographical locations and/or be operationally distinct from each other. Care coordinators trained in MOL will be asked to avoid discussing the approach with practitioners based in other teams. Care coordinator participants will receive supervision to support the delivery of the intervention for 6 months. The final follow up will be at 6 months.
Early Intervention in Psychosis (EIP) team eligibility criteria: EIP teams operating within three participating NHS Trusts (Greater Manchester Mental Health [GMMH], Lancashire and South Cumbria NHS Foundation Trust [LSCFT], and Merseycare) will be included in the study when organisational support is provided for at least two care coordinators to engage with the MOL training and supervision. Care coordinator participant eligibility criteria: 1. Working within EIP services based within participating NHS Trusts 2. Likely to remain in their current post for the duration of the study 3. Have organisational support from their employer to engage with MOL training and supervision 4. Willing and able to engage with MOL training and supervision 5. Provide informed consent to participate in the study Service user participant eligibility criteria: 1. Current users of an EIP service that is included in the study 2. Have an allocated care coordinator who is participating in the study 3. Due to remain under the care of their EIP service until the end of the study 4. Have the capacity to provide informed consent to participate in the study 5. Have sufficient written and verbal English language skills to complete outcome measures and engage with the MOL intervention 6. Aged 18 years or older
Does not meet the inclusion criteria