ECLIPSE Study 2: Comparison of acceptability between CRT methods
Research type
Research Study
Full title
Enhancing Cognition and quality of LIfe in the early PSychosEs (ECLIPSE) - Study 2: Comparison of acceptability between methods of implementation
IRAS ID
185701
Contact name
Til Wykes
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Summary of Research
The study 2 comes under the ECLIPSE umbrella, which is a randomised controlled trial evaluating the cognitive-remediation therapy (CRT) for early psychosis. In Work Package 1 of the ECLIPSE, data will be collected from: (i) service users and staff on treatment acceptability (Studies 1 and 2), (ii) service users and staff on preference domains for methods of treatment implementation (Study 3) and (iii) staff on organisational climate (Studies 4 and 5). The main aim of current study (Study 2) is to compare the service users’ and staff’s acceptability between methods of implementation of cognitive-remediation therapy in Early Intervention Services (intensive CRT, independent CRT, group CRT).
The data will be collected for 510 service users at the end of CRT therapy(Study 9 – ECLIPSE cognitive-remediation trial) as an online survey. Staff satisfaction will be collected 12 months post-implementation.
Service user and staff will be recruited across six sites (ten NHS Trusts): Birmingham and Solihull, Coventry and Warwick, Sussex, Peterborough and Norwich, South London, which will take part in the CRT trial. The trial eligibility criteria are: individuals attending an Early Intervention Service for at least six months, aged between 16 and 35 with an ICD-10 diagnosis of non-affective psychosis. Staff will be members of Early Intervention Services. There is no specific exclusion criteria and no age restrictions.Summary of Results
Enhancing Cognition and quality of LIfe in the early PSychosEs (ECLIPSE) - Study 2: Comparison of acceptability between methods of implementation
Cognitive Remediation is effective in improving cognition and functioning in people with a diagnosis of psychosis, but it is implemented in a variety of ways. We conducted a randomised controlled trial of three cognitive remediation delivery methods to investigate which one was cost-effective. We measured the benefits on cognitive tests and on recovery goals achieved. We compared the treatment with treatment as usual and found that one-to-one and group cognitive remediation delivery improved both cognition and functioning and both were better than Cognitive Remediation undertaken independently when compared to usual treatment. Cognitive remediation utilised the computerised CIRCuiTSTM programme.
It is also important to understand whether this therapy is acceptable and whether service users are satisfied with how the cognitive remediation therapy is provided and whether their level of satisfaction affects the benefit they receive so we measured it as part of our study. To do this, we co-developed the Cognitive Remediation Satisfaction scale by recruiting 8 service-users (median age 28) to participate in 2 focus groups during which they discussed the content and format of a potential measure. The focus group facilitators were service-user researchers who transcribed the discussions and undertook a thematic analysis to generate a draft satisfaction measure. Four key themes emerged: therapy hours (understanding and use of different cognitive remediation components); the therapist (understanding the therapist’s role and levels of support); the therapy effects (applying skills learnt from Cognitive Remediation into everyday life and the personal effect of undertaking and ending the therapy); and using the computer (ease of computer use and the Cognitive Remediation programme).
This draft satisfaction measure was completed by 144 participants who had received therapy in an on-line survey. We used these data to refine the measure and checked it for statistical robustness using three standard criteria to produce a final measure and tested its validity by showing it was related to (i) the number of therapy hours and another measure that can reflect how the person considers therapy satisfaction (ii) the Working Alliance Inventory score. There were significant Cognitive Remediation Satisfaction associations with both measures suggesting convergent validity.
The mean age of the 144 participants was 26 years, 25% were women, 45% white and 32% were employed or in education. They were representative of the larger group participating in therapy. There was no significant relationship between how therapy was provided and satisfaction scores, but subjective improvement from therapy was significantly correlated with the satisfaction score. When this was investigated in more detail, we found that only the correlations in the group and one-to-one Cognitive Remediation therapy were significant. Better satisfaction was related to more completed therapy hours, and more therapy hours was associated with better achievement of personal recovery goals measured with the Goals Attainment Scale. But better satisfaction was not related directly to achieving personal goals.
We concluded that satisfaction with therapy is related to engagement with therapy, but not with recovery or therapy method. Satisfaction is not the key to increasing functioning, but it is a secondary desirable outcome that relates to treatment engagement.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1816
Date of REC Opinion
3 Dec 2015
REC opinion
Further Information Favourable Opinion