Development and evaluation of adapted cognitive behaviour therapy for social anxiety disorder in autistic adults: a cluster randomised controlled trial

Research Question: What is the effectiveness and cost-effectiveness of cognitive behaviour therapy (CBT) for social anxiety disorder adapted for autistic people compared with standard CBT? Background: Social Anxiety Disorder (SAD) is an overwhelming fear of social situations characterised by fear of negative evaluation by others. SAD can have a significant negative impact on people’s function and adversely impact co-existing mental health conditions. Cognitive Behaviour Therapy for SAD based on the Clark and Wells, 1995 [1] model is termed Cognitive Therapy for SAD (CT-SAD). CT-SAD an evidence-based, NICE recommended treatment [2] routinely offered by NHS talking therapy services (NHS-TT) in England. Autism, a neurodevelopmental condition, characterised by social communication difference and a pattern of restricted, repetitive and stereotyped behaviours, interests and activities is associated with high rates of mental health problems including SAD. SAD negatively affects autistic people’s function and quality of life [3-4]. The cognitive, behavioural and attentional processes outlined in the model underpinning CT-SAD have been shown to be relevant for autistic people [5]. CBT for other anxiety disorders has been successfully adapted to meet the needs of autistic people [6]. Autistic people have communication and neurocognitive difference that can mean standard CBT approaches are less accessible to them. Autism adapted CBT emphasises behavioural change techniques and scaffolds executive function differences such as variations in cognitive flexibility [7]. However, CT-SAD targets cognitive processes as the primary mechanism of change and is then inherently less suited to the needs of autistic people. CT-SAD has not been adapted for or investigated in respect of effectiveness for autistic people. Treatment evaluations have been single cases or small pilot trials, and the elements of CT-SAD have not been systematically investigated [8]. Aims and Objectives: This research aims to (i) adapt CT-SAD for autistic people (CT-SAD-A) through co-production and (ii) test the effectiveness and cost-effectiveness of CT-SAD-A compared with standard CT for SAD. Methods: Co-production meetings with autistic adults, carers and CBT therapists will support the development of CT-SAD-A. A staggered series of individual cases will try-out and provide feedback to enable refinement of CT-SAD-A. A cluster randomised controlled trial (RCT) with internal pilot will investigate the effectiveness of CT-SAD-A compared to CT-SAD. NHS-TT services (N=24) will be randomly allocated to CT-SAD-A or CT-SAD and provided with training in the allocated intervention. Autistic adults (N=480) attending NHS-TT will be screened at triage assessment for SAD and if eligible invited to take part in the trial. Primary outcome will be the self-reported Social Phobia Inventory (SPIN) 18 weeks following the start of treatment. Secondary outcomes will be measured at 18, 36 and 52 weeks and include measures of quality of life, health economic measures, social anxiety, mood, anxiety, positive and negative affect, and patient perceived success of treatment. Qualitative interviews with autistic adults and CBT therapists will inform which elements of the intervention people experienced as helpful. Autistic people, their supporters and CBT therapists will be involved at all stages in the research to support the development, conduct and dissemination of the study.