Protocol for a feasibility study and randomised pilot trial of a low intensity psychological intervention for depression in adults with autism: The Autism Depression Trial (ADEPT)

IntroductionHigh rates of co-occurring depression are reported in Autism Spectrum Disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group CBT for co-occurring depression, but no randomised trials investigating low intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression. Methods and AnalysisA feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is underway as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help (GSH): a low intensity psychological intervention based on Behavioural Activation adapted for ASD or Treatment as Usual (TAU). Outcomes including depression symptoms, anxiety, social function, and service use will be measured at 10, 16 and 24 weeks post randomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design. Ethics and DisseminationEthical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership (AWP) and Northumberland, Tyne & Wear (NTW) NHS Trusts To our knowledge, this is the first study of a low intensity intervention for depression in adults with Autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study, and presentations at national and international conferences. Trial Registration: Current Controlled Trials ISRCTN54650760 assigned 28/09/2016 http://www.isrctn.com/ISRCTN54650760