Abstract
BackgroundAt least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment. Cognitive behaviour therapy for psychosis (CBTp) is the only NICE-recommended individual therapy for psychosis, with effects on symptoms, distress and quality of life. Yet <10% of service-users receive it and 94% of trusts struggle to provide it. Of those offered it, 22–43% refuse or do not attend. We have developed a new pre-CBTp informed choice intervention to address knowledge and attitudes that influence uptake and implementation and now want to test it in a feasibility trial.MethodsThe design is a two-arm, feasibility randomised controlled trial (RCT), with 1:1 randomisation, stratified by participant group and site. Participants are 40 psychosis patients and 40 clinicians, who are ambivalent towards uptake or implementation of CBTp. Sites are community and inpatient services in Sussex and London. The intervention is a pre-CBT digital psychoeducation intervention designed to address identified knowledge and attitudinal barriers to uptake and implementation of CBTp, incorporating behaviour change mechanisms, and supported by animated introductory, patient and clinician stories. The comparator is the NHS choices website for CBT. The primary aim is to assess clinical feasibility (recruitment, randomisation, acceptability, use, delivery, outcome measurement, retention). A secondary aim is a preliminary evaluation of efficacy. Outcomes will be assessed at baseline, post intervention, and one-month follow-up (blind to treatment arm). The primary efficacy outcome is likelihood of offering/taking up CBTp. Secondary outcomes include knowledge and attitudes towards CBTp, illness perceptions, empowerment, psychological wellbeing (patients only) and CBTp implementation (clinicians only). Use of the intervention and CBT behaviours during the follow-up period will be recorded and captured in a feedback questionnaire. Use, acceptability and experience of outcome assessment will be explored in qualitative interviews with participants (n = 6 per group). The efficacy evaluation will report descriptive data, key model parameters and 95% highest probability density intervals in a Bayesian growth model.DiscussionThis is the first feasibility trial of a digital ‘informed choice’ decision aid for the implementation of CBTp. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted.Trial registrationISRCTN registry, ISRCTN53107879. Registered prospectively on 2 August 2017.
Highlights
At least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment
This will be done through monitoring using the study Consolidated Standards of Reporting Trials (CONSORT) diagram, through system analytics on use of the digital intervention during the one-month period, through the user feedback questionnaire collected at the end of one month, and through a qualitative interview with a sub-sample of those receiving the intervention (n = 6 per group) at the end of one month
The intervention has been designed following extensive qualitative and quantitative analysis and user-centred design research. It focusses on the needs, knowledge and attitudes of psychosis patients and clinicians, and is a psycho-educational and decision-aid tool to facilitate high quality, informed and collaborative discussions and choices regarding the implementation and uptake of CBT for psychosis
Summary
The design is a two-arm, feasibility randomised controlled trial (RCT), with 1:1 randomisation, stratified by participant group and site. Participants are 40 psychosis patients and 40 clinicians, who are ambivalent towards uptake or implementation of CBTp. Sites are community and inpatient services in Sussex and London. The intervention is a pre-CBT digital psychoeducation intervention designed to address identified knowledge and attitudinal barriers to uptake and implementation of CBTp, incorporating behaviour change mechanisms, and supported by animated introductory, patient and clinician stories. The primary aim is to assess clinical feasibility (recruitment, randomisation, acceptability, use, delivery, outcome measurement, retention). The primary efficacy outcome is likelihood of offering/taking up CBTp. Secondary outcomes include knowledge and attitudes towards CBTp, illness perceptions, empowerment, psychological wellbeing (patients only) and CBTp implementation (clinicians only). Acceptability and experience of outcome assessment will be explored in qualitative interviews with participants (n = 6 per group). The efficacy evaluation will report descriptive data, key model parameters and 95% highest probability density intervals in a Bayesian growth model
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