ArticleTrials2018
The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital 'informed choice' intervention to improve attitudes towards uptake and implementation of CBT for psychosis.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.
- Psychosocial Interventions in the Rehabilitation and the Management of Psychosis and Schizophrenia: A Systematic Review on Digitally-Delivered Interventions.Actas espanolas de psiquiatria · 2025Pooled it
- The service user experience of SlowMo therapy: A co-produced thematic analysis of service users' subjective experience.Psychology and psychotherapy · 2022Trial
- Managing emotions in psychosis: Evaluation of a brief DBT-informed skills group for individuals with psychosis in routine community services.The British journal of clinical psychology · 2022Trial
- The impact of Patient and Public Involvement in the SlowMo study: Reflections on peer innovation.Health expectations : an international journal of public participation in health care and health policy · 2022Trial
- The Impact of a Gamified Mobile Mental Health App (eQuoo) on Resilience and Mental Health in a Student Population: Large-Scale Randomized Controlled Trial.JMIR mental health · 2023Article
- Exploring the Development, Validity, and Utility of the Short-Form Version of the CHoice of Outcome In Cbt for PsychosEs: A Patient-Reported Outcome Measure of Psychological Recovery.Schizophrenia bulletin · 2021Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
12 authors at 4 institutions in 1 country.
Funding
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. DISCUSSION: This 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.