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Table 1 Protocol changes

From: Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2)

Protocol versionDetails 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.