The Autism Depression Trial – 2 (ADEPT-2)
Research type
Research Study
Full title
A multicentre randomised controlled trial of guided self-help versus treatment as usual for depression for autistic adults
IRAS ID
310263
Contact name
Ailsa Russell
Contact email
Sponsor organisation
University of Bath
ISRCTN Number
ISRCTN17547011
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Individuals with Autism Spectrum Disorder are 3-4 times more likely to be affected by depression than the general population. For individuals with mild-moderate depression in the general population, low-intensity talking therapies drawing on behavioural activation principles are recommended. There is currently no evidence supporting the use of treatments in autistic people with depression. 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 qualitative study. The GSH intervention developed for the RCT includes materials for nine 45-minute individual sessions, based on behavioural activation principles, facilitated by a 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. We will recruit autistic adults (n=248) from NHS adult autism services, NHS community mental health services and social care/3rd sector services. Participants with a clinical autism diagnosis and current depression, defined as having a PHQ-9 score ≥ 10, and who fully consent to participate will be included in the study. 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. The qualitative study will examine participant and therapist views and experiences of the intervention and the trial. Qualitative findings will identify things that may impact upon the intervention acceptability, effectiveness and implementation. We will co-produce therapist training resources with the PAG to enable rapid dissemination of the intervention.
REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0091
Date of REC Opinion
14 Jun 2022
REC opinion
Further Information Favourable Opinion