Title: A multicentre randomised controlled trial of guided self-help versus treatment as usual for depression for autistic adults
Funder: Department of Health and Social Care

Abstract: Depression, or low mood, has a negative impact on people’s lives. Autistic people are affected by depression more than non-autistic people. It can be difficult for autistic people to access therapy to help depression because of differences in the way they think, communicate and behave. The NHS offers therapies for depression which were not developed for autistic people. The psychological therapists delivering these treatments are not trained in working with autistic people. There are a handful of research studies which have investigated therapy for depression in autistic people, but none of these were large-scale studies which looked at a depression-specific therapy in adults. Although we know autistic people are more likely to need therapy for depression than non-autistic people, there is no good quality evidence to support the use of NHS psychological therapy for depression with autistic adults. _x000D_ _x000D_ We conducted a pilot study to see whether NHS psychological therapy for depression could be adapted to meet the needs of autistic people. We developed a treatment called Guided Self-Help (GSH), with materials for nine individual sessions for autistic people with depression. GSH is different because the written information is adapted to suit autistic people, the sessions are longer than those in standard treatment and the therapists receive extra training and supervision to work alongside autistic people. Autistic people helped us to make the written materials. We carried out a study to see if the treatment was safe and feasible, called a feasibility randomised controlled trial. Seventy autistic adults took part in the study. The feasibility study was successful. Most people who had GSH attended all their sessions and said they found it acceptable and helpful. _x000D_ _x000D_ It is now important to carry out a large-scale study to find out if GSH works and is cost-effective as a psychological treatment for depression for autistic adults. To find this out, we will ask autistic adults with depression to take part in the research. If they agree to take part they will be randomly given the new GSH treatment or the treatment which is usually available in their area. There will be 124 people in each group, 248 people in total. Depression will be measured before they start treatment, and 4, 8 and 12 months after this. Depression will be measured using self-report questionnaires given by researchers who do not know which treatment people are receiving. We will ask people to also complete measures of anxiety, quality of life and other questionnaires which will tell us which treatment is the most cost-effective. We will interview people who take part in the trial to find out their experience of the trial, the treatment and any long term benefits they notice at 12 months. We will also interview people who decide not to take part in or withdraw from the trial so that we can make sure we are doing everything we can to include everyone’s views. There will be independent committees and an advisory group of autistic adults to help the research team design and deliver the study well.

Lay abstract: Autistic people are 3-4 times more likely to be affected by depression than the general population. Low-intensity psychosocial interventions drawing on behavioural activation principles are recommended as effective treatments for depression. There is currently no evidence supporting the use of such treatments for autistic people with depression. _x000D_ _x000D_ We plan to establish the clinical and cost effectiveness of an adapted low-intensity psychological intervention for depression in autistic adults. We will conduct a multi-centre, 2-group parallel randomised controlled trial (RCT) of Guided Self-Help (GSH) compared to treatment as usual (TAU) with an internal pilot phase and nested qualitative study. The GSH intervention developed for the RCT comprises materials for nine 45-minute individual sessions, based on behavioural activation principles, facilitated by a low-intensity therapist trained to support autistic adults in their use of the materials. Low-intensity therapists have foundation knowledge and training in cognitive behaviour therapy (CBT) protocols. _x000D_ _x000D_ We will recruit autistic adults (n=248) from NHS adult autism services, NHS community mental health services and social care/third sector services. Participants with a clinical autism diagnosis and current depression, defined as having a PHQ-9 score equal to or greater than 10, and who fully consent to participate will be included in the study. _x000D_ Participants will be randomised to either GSH or TAU. Outcome measurement will be at baseline and 4, 8- and 12-months post-randomisation, assessing depression symptoms, anxiety, quality of life and an economic evaluation. A self-report measure of depression, the Beck Depression Inventory-II (BDI-II) will be the primary outcome measure. _x000D_ The qualitative study will examine participant and therapist views and experiences of the intervention and the trial. Qualitative findings will identify factors that may impact upon the intervention acceptability and effectiveness and implementation._x000D_ _x000D_ The study will have Patient and Public Involvement on the Trial Steering Committee. A Patient Advisory Group (PAG) will provide advice about the conduct of the trial from a patient perspective and support the research team in development of patient-facing resources, activities to foster participant connectedness with the study, dissemination activities throughout the study and co-production of therapist training resources to enable rapid dissemination of the intervention.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH