Specialty: Mental Health, Primary sub-specialty: Developmental disorders - Autism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. ADI-R confirmed ASC diagnosis 2. Aged 18 and over 3. Normal or corrected-to-normal vision 4. Fluent English speakers
Exclusion criteria
Exclusion criteria: 1. Age below 18 years 2. Past head injury or neurological disorders 3. History of major medical or psychiatric disorder (other than anxiety and co-morbid depression) 4. Cognitive impairment 5. History of substance or alcohol dependence 6. Heart disease 7. Obesity (body mass index > 30kg/m2) 8. Hypertension (>140/90 mm Hg) 9. Pregnancy 10. Asthma/respiratory illness 11. Migraines 12. Claustrophobia or other MRI exclusions 13. Upper age limit of 65
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/01/2021: Spielberger STAI trait anxiety at 3 months _____ Previous primary outcome measure: Trait and state anxiety is measured using the STAI trait anxiety score State-Trait Anxiety Inventory determined from the STAI (State-Trait Anxiety Inventory questionnaire) at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety is measured using the STAI state and trait anxiety scores at 1 year 2. Generalized anxiety is measured using the GAD7 score at three months and one year 3. Generalised anxiety is measured using the diagnosis criteria (MINI) met for generalized anxiety disorder at 1 year 4. Use of anxiolytic medication is measured using patient interviews at one year 5. Recovery is measured using the MINI criteria for anxiety disorder and the Spielberger trait anxiety score at three months and one year 6. Relapse is measured using the diagnostic criteria of the MINI generalised or social anxiety disorder with Spielberger trait anxiety score at one year 7. Trait Interoceptive prediction error on behavioural tests of interoceptive ability (error measured from z-score of heartbeat detection score accuracy -subjective (questionnaire and confidence) ratings of interoceptive 'sensibility' at 3 months and 1 year 8. Metacognitive interoceptive awareness measured from performance confidence correspondence (ROC curve analyses) at 3 months and 1 year 9. Clinical predictors of therapy response on ASD-related measures, i.e., cognitive, verbal and performance IQ, and ADI-R scores on dimensions of 1) social interaction, 2) communication and language and 3) repetitive stereotyped interests and behaviours predict magnitude of change in Spielberger anxiety score at 3 months and 1 year 10. Functional neural datasets is measured using SPM (Statistical Parametric Mapping) at 3 months and their relation to symptom response to treatment 11. Established efficacy of implementable software solution (beta testing–comparison against laboratory training methods therapist-measured ratings of ease-of-use) at 1 year 12. Participant’s capacity to control the occurrence of mindwandering and contents of their experience is measured us | — |
Countries
England, United Kingdom