Depression in autistic adults Mental and Behavioural Disorders
Conditions
Interventions
Participants will be adults (aged =18 years) with a diagnosis of Autism Spectrum Disorder (ASD) and current depression measured by the PHQ-9. Potentially eligible participants will be recruited from N
Sponsors
University of Bath
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged =18 years 2. A clinical diagnosis of autism spectrum disorder (ASD) 3. Current depression measured by the PHQ-9 with a score of =10 at screening 4. Can be on medication but dose should be stable for 6 weeks prior to randomisation
Exclusion criteria
Exclusion criteria: 1. Risk of suicide - participants who endorse a score of 3 on Item 9 of the PHQ-9 will be followed up by the lead clinical researcher on each site to assess suicidal risk. Where clinic assessment or research follow-up is indicative that there is a current risk of suicidality such that a low-intensity intervention would not be clinically appropriate, this will be communicated to the relevant health care professional (e.g. referring ASD clinic and/or GP) and the participant will be excluded from the study. 2. Participants who report that they have attended >6 sessions of individual psychological treatment within a CBT framework over the past 6 months will be excluded from the study 3. A history of psychosis 4. Current alcohol/substance dependence 5. Untreated epilepsy 6. English literacy levels such that the treatment materials are inaccessible without reasonable adjustments and a supporting person is not available. This will be established by reviewing the case notes for record of cognitive/educational assessment indicating significant literacy difficulties, on information provided by the referring clinician and/or during the eligibility assessment when it is difficult to gain consent to participate in the research because of difficulties reading and thus comprehending the study information sheet. The researchers will strive to include all adults in the study if supporters are available to help an individual access the treatment where written/spoken English presents a barrier. 7. Taking part in an interventional study for mental health
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression assessed using the Beck Depression Inventory-II (BDI-II) at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/09/2024: 1. Depressive symptoms measured using: 1.1. BDI-II depression score at 32 and 52 weeks post-randomisation 1.2. Patient Health Questionnaire-9 (PHQ-9) at 16 and 52 weeks 1.3. Patient rating of global change at 16, 32 and 52 weeks 2. Quality of life measured using the EQ-5D 5L and EQ-VAS at 16, 32 and 52 weeks 3. Anxiety measured using the General Anxiety Disorder-7 (GAD-7) at 16 and 52 weeks 4. Positive and negative affect measured using the Positive And Negative Affect Schedule (PANAS), measured at 16- and 52-weeks 5. Work and social function measured using the Work and Social Adjustment Scale (WSAS) measured at 16 and 52 weeks 6. Carer impact measured using Depression Anxiety Stress Scales (DASS), and Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at 16 and 52 weeks 7. Resource use measured via a participant-reported resource-use questionnaire, including ModRUM, the Work Productivity and Activity Impairment: General Health (WPAI-GH) and bespoke questions at 16, 32 and 52 weeks 8. Cost-effectiveness measured via quality-adjusted life years (QALYs), generated from the EQ-5D-5L, and resource use questionnaire at 16, 32 and 52 weeks Amended from the secondary outcome measure phrasing below (no change to outcome measures themselves): Measured at 16 and 52 weeks: - 1. Depressive symptoms measured using the BDI-II depression score and Patient Health Questionnaire-9 (PHQ-9) and Global Rating of Change 2. Quality of life measured using EQ-5D-5L and a study-specific questionnaire 3. Anxiety measured using GAD-7 4. Positive and negative affect measured using Positive And Negative Affect Schedule (PANAS) 5. Work and social function measured using the Work and Social Adjustment Scale (WSAS) 6. Impact on carer measured using the Depression Anxiety Stress Scales (DASS) and Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) 7. Resource use/cost-effectiveness measured using EQ-5D-5L (to calc | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed