Table 1 Approved amendments to protocol
Protocol version | Details of change |
|---|---|
Version 3 (31/07/22) | 1) Removal of SCID-5 Clinical Interview from the screening assessment 2) Revision to Information About You (version 2) demographics measure within the screening assessment – to be consistent with current recommendations from the Office of National Statistics 3) Revision to Safety Reporting and Monitoring—adverse events relating to mental health only need to be captured if the participant requires additional contact from care teams. |
Version 4 (11/09/22) | 1) Further definition of the Events applicable in the trial and how they will be reported and recorded 2) Explication of the primary and secondary outcomes 3) Clarification of the relationships between the CTU, Trial Statistician and RAs 4) Revisions to allow the inclusion criteria to reflect the changing nature of service provision 5) Inclusion of the level of 'exposure' to the intervention 6) Creation of a referral form (version 1 – 11/09/22) and clarification of the role of the Care Co-ordinator within the referral process 7) Identification of a temporary PI at the CNTW site whilst the PI is on planned sick leave 8) The revision of items 7 and 8 of the Consent Form (patient participants; version 2 – 14/09/22) to explicate the process of session recordings being securely transferred between sites and facilitate CTU receipt of the Consent forms |
Version 5 (11/11/22) | 1) Clarification within the inclusion criteria of the ICD codes that are covered by the term 'psychosis' 2) The insertion of a timeline for the Implementation Modelling within the GANTT chart 3) Revision of the referral form (version 2 – 07/11/22) to remove the eligibility criteria and to request information about the patient's awareness of the referral |
Version 6 (08/03/23) | 1) Clarification on the reporting process for SAEs and AEs to decrease risk of unblinding events 2) Removal of the previous Safety reporting flowchart and addition of reference to external safety reporting flowchart 3) Inclusion of the opportunity for participants who receive the study intervention to participate in a qualitative exploration of their use of the learning resources 4) Minor changes in language following an equality, diversity and inclusion review 5) Documented changes to study team |