Treatment of depression in autistic adults Mental and Behavioural Disorders
Conditions
Interventions
PROJECT DESIGN
This project will use a randomised multiple baseline case series design to evaluate if ADepT is feasible, acceptable, and effective in treating depression in autistic adults. Up to 15 p
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18+ years old 2. Identify depression as their primary presenting problem 3. Meet diagnostic criteria for a current episode of Major Depressive Disorder (MDD; using Structured Clinical Interview for Diagnosis) 4. In a clinical range (> 10) on a validated depression measure, the Patient Health Questionnaire 9 (PHQ-9) 5. Have a diagnosis of Autism Spectrum Disorder (or Asperger's if diagnosed prior to DSM-5 criteria change) and/or score above cut off on a screening measure (Autism Spectrum Quotient; AQ-10) 6. Present with a level of clinical complexity that is appropriate for the primary care NHS-TT setting 7. Sufficient working knowledge of written and spoken English to engage and make use of therapy and complete research assessments without translation or use of an interpreter 8. Consent for their General Practitioner (GP) to be informed of their participation 9. Live in the catchment area for the Devon Integrated Care Board and are registered with a Devon GP
Exclusion criteria
Exclusion criteria: 1. A level of risk to the self or others that cannot be safely managed in the clinic setting (e.g., an active suicidal plan) or that would significantly impair engagement in therapy. 2. Significant cognitive impairment (e.g. unable to engage in therapy due to verbal comprehension, memory, and abstract thinking impairments). 3. Current or historical psychotic symptoms and schizophrenia, indications of current mania, substance misuse issues, problematic eating that could interfere with engagement in therapy. 4. Current moderate to severe personality disorder and/or antisocial personality traits that requires secondary/tertiary care management 5. Features of a learning disability that the clinician judges would interfere with engagement in therapy and capacity to complete research assessments 6. Any severe, life-threatening, or clinically significant disease or disorder that in the assessing clinician’s judgment may either put the participants at risk because of participation in the trial, may influence the result of the trial, inhibit the participant’s ability to participate in the trial, or cannot be safely managed within the clinic setting 7. Undertaking any other psychological intervention at the time of the trial 8. Currently lacking capacity to give informed consent 9. Presence of another area of difficulty that the therapist and client believe should be the primary focus on intervention (for example, Post-Traumatic Stress Disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Recruitment rate measured using the number of clients recruited and over what time frame in the research recruitment log at the end of the study (continuation rule: ten or more participants can be recruited over six months) 2.Treatment engagement measured using data from the clinical treatment records on the number of clients who completed treatment with a planned discharge and the number of clients attending at least 8 sessions (50% of acute treatment dose), at the end of the acute treatment phase (continuation rule: > 60% of clients complete a minimum adequate dose of treatment [>8 sessions] with a planned discharge) 3.Satisfaction with treatment measured using the number of clients and therapists rating treatment as acceptable, satisfactory and that they would recommend it to others from a bespoke three-item rating scale, with each question being rated on a five-point Likert scale ranging from strongly disagree to strongly agree at the end of the acute treatment phase (> 60% of clients rate treatment as acceptable, satisfactory and that they would recommend treatment to others) 4.Patient safety measured using any disclosed incident (disclosed by participant, clinician, administrative team, or research team) data reported on a bespoke adverse events form used in the host service, which will be assessed by the clinic lead and project lead to determine if the incident was treatment or trial-related, on the number of serious incidents that could be clearly attributed to the intervention or research participation at the end of the study (continuation rule: no serious incidents occurred that could be clearly attributed to case series participation) 5.Preliminary signal of clinical improvement during treatment, measured using the number of clients showing at least reliable improvement pre- to post- treatment and/or a change in slope/level in the direction of clinical improvement in time series analysis of depression, anxiety and/or wellbeing (continuation rule: > 60% | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be collected weekly during the baseline phase, treatment phase, and two-month post-treatment phase: 1. Depression symptom severity measured using the Patient Health Questionnaire (PHQ-9) 2. Anxiety symptom severity measured using the Generalized Anxiety Disorder scale (GAD-7) 3. Positive wellbeing experiences measured using the Warwick-Edinburgh Mental Wellbeing Scale short form (WEMWBS-SF) 4. Recovery of quality of life measured using the Recovering Quality of Life tool (ReQoL-10) 5. Psychosocial impairment measured using the Work and Social Adjustment Scale (WSAS) The following secondary outcome measures will be collected at intake, pre-treatment, post-treatment, 2-month follow-up and 1-year follow-up extended assessment: 1. PHQ-9, GAD-7, WEMWBS-SF, ReQOL-10, WSAS as described above. 2. Anhedonia severity (a loss of interest and pleasure) measured using the Snaith Hamilton Pleasure Scale (SHAPS) 3. Quality of life in autistic adults measured using the Autism Spectrum Quality of Life Measure (ASQoL), a 9-item self-report measure to assess 4. Satisfaction in key life domains measured using the DIALOG scale 5. Index the logic model underpinning the ADepT intervention measured using the ADepT Outcome Tool | — |
Countries
England, United Kingdom
Contacts
Public ContactHope Trimmer
Outcome results
None listed