Increasing access to cognitive–behavioural therapy for patients with psychosis by evaluating the feasibility of a randomised controlled trial of brief, targeted cognitive–behavioural therapy for distressing voices delivered by assistant psychologists: the GiVE2 trial

Background Cognitive–behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.