| Popis: |
Background Despite the effectiveness of cognitive remediation, it is not widely implemented because we do not know whether teams will accept it, how much therapist time is needed, whether there are factors which predict lower benefits, whether it is cost-effective and what is required for large-scale roll-out. Objective To understand the factors that will enhance implementation and benefits of cognitive remediation in Early Intervention Services. Design Four work packages: (1) focus groups and interviews exploring the development of satisfaction and preference measures for staff and service users; participant team interviews to collect data, before and after introducing cognitive remediation, to understand team dynamics; (2) an observational study of a newly developed therapist e-training programme; (3) a multiarm multistage four-arm randomised controlled trial comparing different amounts of therapist input with Treatment as Usual; and (4) an analysis of trial data to understand potential mediating and moderating factors that affect treatment benefits. Setting Early Intervention Services in the United Kingdom National Health Service. Participants Staff and service users in touch with Early Intervention Services. Interventions For the e-training, we piloted and then provided an e-learning system for training cognitive remediation therapists. For the randomised trial, we provided a cognitive remediation software programme (CIRCuiTS™,King’s College London, London) that was delivered in three conditions, all offering up to 42 sessions of cognitive remediation. The conditions were: Intensive (one to one with a therapist), Group treatment with a therapist, Independent with drop-in sessions. Main outcome measures Work package 1: We developed two satisfaction measures and tested a team dynamic model. Work package 2: Feasibility and acceptability questionnaire, time to complete e-training modules. Work package 3: The personal recovery measure – Goal Attainment Scale. Results Work package 1: The service user satisfaction with cognitive remediation was reliable and valid. Although it did not show statistically significant differences between the arms of the trial, the most preferred methods (Group and Intensive) had higher associated satisfaction. Team leadership and especially a flattened hierarchy, resources and time were identified as vital for implementation. Our team dynamic model supported the importance of leadership in influencing organisational climate, which then affected staff attitudes. However, this was only significant before staff had any experience of their patients receiving cognitive remediation. Although the sample was much smaller after therapy, this may indicate that experience of the beneficial therapy changes team dynamics. Work package 2: The e-training modules were completed by 43% of the recruited participants. They judged the training to be feasible and acceptable, but it did take longer to complete than expected. COVID-19 with the increased workload may have had some effects, but our data exploration shows that it was individuals who had most recently qualified who had the best outcomes. This may be because of a lighter workload or that they were more used to online training. Adaptations suggested are now being implemented. Work package 3: Following the interim analysis we closed two arms – Independent therapy and Treatment as Usual. Four hundred and forty-eight patients consented and 377 were eligible and completed baseline assessment. They were randomised: Group 134, Independent 65, Intensive 112 and Treatment as Usual 66. At post therapy, there were no differences between Group and Intensive or between Independent and Treatment as Usual, but the combined Group and Intensive versus Treatment as Usual was significant (mean difference: 5.734; standard error = 1.958; p = 0.003; lower confidence interval = 1.898 to upper confidence interval = 9.571). Our economic analysis showed that Group and Intensive cognitive remediation were not different with respect to quality-adjusted life-years (difference £150, 95% confidence interval –£1132 to £1905). Both conferred significant benefit compared with standard care (Group and Treatment as Usual: difference £257, 95% confidence interval –£1694 to £2615; Intensive vs. Treatment as Usual: difference £260, 95% CI –£1654 to £2239). Their cost–benefit for quality-adjusted life-year improvement was well below the National Institute for Health and Care Excellence threshold for adopting the intervention to National Health Service services. Work package 4: Cognition had a small mediation effect, and negative symptoms moderated the transfer of cognitive benefits to goal attainment. Limitations The trial suffered from recruitment difficulties which were overcome when we switched from block to individual randomisation. The final target was large enough to test our main outcomes and moderating and mediating variables. Conclusions Cognitive remediation should be provided in the National Health Service, involving a trained therapist on a Group or Intensive format with team and training support. Future work We have a large database and will continue to investigate factors that affect cognitive remediation benefits. Study registration This study is registered as ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0612-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 4. See the NIHR funding and Awards website for further award information. Plain language summary Cognitive problems in people with schizophrenia predict functional recovery even with the best-possible rehabilitation opportunities. One psychological treatment, cognitive remediation can improve both cognitive and functional recovery, such as in social relationships and occupational achievements. We investigated the optimal way of delivering computerised cognitive remediation in Early Intervention Services by incorporating service user and staff views. Our work involved exploring what treatment factors are important to service users, developing two bespoke cognitive remediation satisfaction measures for service users and service providers. Our investigation of team dynamics suggested that a more flexible leadership style together with increasing resources might be most suited to successful delivery. One challenge for large-scale roll-out of cognitive remediation is therapist training opportunities, so we developed an online programme and then tested it in the United Kingdom and, with a few adaptations, it can be provided to the National Health Service. Although cognitive remediation is effective, we do not know how much therapist time produces therapy benefits, so we conducted a trial comparing three options for cognitive remediation treatment that differed in the amount of the therapist time (Independent, Group and Intensive). We compared these options with a no-treatment group. We investigated benefits of each option in 377 participants from Early Intervention Services. The main benefit assessed was whether participants could achieve their personal goals that were set before therapy began. Although we found no change in a social or occupational functioning scale rated by an observer, the Group and Intensive cognitive remediation produced significant achievements in the participants’ own personal goals compared with those who did not receive therapy or who carried out therapy on their own. We also found that any cognitive remediation therapy option improved thinking skills. Group and Intensive therapy were also cost-effective. Overall, cognitive remediation was acceptable and well liked by service users, so all our data suggest that it should be more easily accessible in the National Health Service. Scientific summary Cognitive remediation (CR) therapy is a psychological intervention targeting cognitive dysfunction associated with psychosis with the goal of improving functional outcomes. Cognitive remediation can improve cognitive and functional recovery, as well as increasing confidence and motivation. Evidence from the largest meta-analysis demonstrated that these effects are durable. National Health Service Early Intervention for psychosis services provide care soon after a diagnosis of psychosis to optimise recovery. Embedding CR in those services may confer long-lasting benefits such as improved social relationships and the opportunity to work or take part in further education. The overarching aim of the Enhancing Cognition and quality of Life in early PSychosiEs (ECLIPSE) research programme was to determine the optimal method of introducing computerised CR therapy (CIRCuiTS™) into NHS Early Intervention Services (EIS) considering improvement in cognitive and social function and cost-effectiveness. The programme was centred on work package 3 (WP3), a randomised, blinded multiarm multisite controlled trial comparing three CR implementation methods with each other and with routine clinical care [Treatment as Usual (TAU)]. To aid the interpretation of WP3 and bolster our recommendations to the NHS, WP1 included a series of studies investigating: patient and staff satisfaction with CR; preference for the methods of CR delivery; and the influence of team organisational climate. Although the CR was computerised and can be completed independently, its effects are boosted via learning, practice and feedback supervised by a therapist. WP2 was a series of studies to design and test an online CR therapist training package to use in their individual teams. Finally, WP4 examined mediators and moderators of the trial results to inform teams about how the clinical features of their individual patients may influence the effect of CR. In WP3, the CR modalities were: Intensive 1 : 1 therapist supervision; Group supervision with one therapist; and Independent (self-determined with infrequent access to therapist supervision). Participants were recruited from EIS in 12 mental health trusts, linked to 6 universities and serving diverse urban/rural populations. They were clinically stable and presented with a non-affective psychotic episode not |
