Administrative information
Title {1} | Increasing access to CBT for psychosis patients: a feasibility, randomized controlled trial evaluating brief, targeted CBT for distressing voices delivered by Assistant Psychologists (GiVE2) |
Trial registration {2a and 2b} | Current Controlled Trials ISRCTN registration number: 16166070. Registered on 05 February 2019. http://www.isrctn.com/ISRCTN16166070 |
Protocol version {3} | Version 1, dated 05/11/18 |
Funding {4} | This project is funded by the National Institute for Health Research for Patient Benefit (project number PB-PG-0317-20029). The views expressed in this publication are those of the authors and not necessarily those of the NHS, NIHR or the Department of Health. |
Author details {5a} | Mark Hayward (corresponding author) School of Psychology, University of Sussex, Brighton BN1 9RH & Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
m.i.hayward@sussex.ac.uk
Clio Berry School of Psychology, University of Sussex, Brighton BN1 9RH
c.berry@sussex.ac.uk
Ben Cameron Research & Development Department, Pennine Care NHS Foundation Trust, 225 Old St, Ashton-under-Lyne OL6 7SR
Ben.cameron@nhs.net
Kate Arnold Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
Kate.arnold2@sussexpartnership.nhs.uk
Katherine Berry Faculty of Biology, Medicine & Health, University of Manchester, M13 9PL
Katherine.berry@manchester.ac.uk
Stephen Bremner Brighton & Sussex Medical School, University of Sussex, Brighton BN1 9RH
s.bremner@sussex.ac.uk
Kate Cavanagh School of Psychology, University of Sussex, Brighton BN1 9RH
k.cavanagh@sussex.ac.uk
David Fowler School of Psychology, University of Sussex, Brighton BN1 9RH
D.Fowler@sussex.ac.uk
Heather Gage School of Biosciences & Medicine, University of Surrey GU27XH
h.gage@surrey.ac.uk
Kathryn Greenwood School of Psychology, University of Sussex, Brighton BN1 9RH
k.e.greenwood@sussex.ac.uk
Cassie Hazell Social Sciences Department, University of Westminster, London W1W 6UW
c.hazell@westminster.ac.uk
Anna-Marie Jones Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
Anna-marie.jones@sussexpartnership.nhs.uk
Sam Robertson Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
Sam.robertson@sussexpartnership.nhs.uk
Clara Strauss University of Sussex & Sussex Partnership NHS Foundation Trust, BN3 7HZ c.y.strauss@sussex.ac.uk |
Name and contact information for the trial sponsor {5b} | Sussex Partnership NHS Foundation Trust, Millview, Nevill Avenue, Hove BN3 7HZ – researchgovernance@sussexpartnership.nhs.uk1 |
Role of sponsor {5c} | The study is sponsored by Sussex Partnership NHS Foundation Trust who will provide at least annual monitoring and audit of the trial and governance procedures. The sponsor played no part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication |
Introduction {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Guided self-help intervention for Voices (GiVE)
Supportive Counselling (SC)
Treatment-as-usual
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Outcomes {12}
Participant timeline {13}
Protocol version | Details of change |
---|---|
Version 2 (2 Jan 2019) | Addition of exclusion criterion for patients currently detained in hospital under a section of the Mental Health Act. |
Addition of Test of Premorbid Functioning as relevant to eligibility assessment of presence of serious learning disability. | |
Addition of statement of intent to audio-record participant assessments. | |
Version 3 (17 Apr 2019) | Reduction of lower age threshold for inclusion from 18 years to 16 years. |
Removal of statement of intent to audio-record participant assessments. | |
Version 4 (14 Aug 2019) | Addition of questionnaire for referring and non-referring clinicians to explore their decision-making around referring patients with psychoRemoval of statement of intentsis to CBT generally and the GiVE intervention specifically as part of process evaluation. |
Revision of qualitative interview with a subsample of therapy participants to explore their experiences of therapy participation, outcomes, and potential mechanisms of change as part of process evaluation. | |
Version 5 (25 Sept 2019) | Typographical correction regarding list of participant assessments. |
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a} and concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded? {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Screening measures
Clinical measures – Primary
Clinical measures – Secondary
Process measures
Health economic measures
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
- Whether the minimal clinically important difference (MCID) is contained within the 95% confidence intervals where:
- ◦ PSYRATS Distress scale of MCID is a 3-point reduction
- ◦ HPSVQ Negative Impact scale MCID is a 2-point reduction
- The level of missing data
- Popularity of the outcome in the literature
- Any other relevant information generated by the process evaluation