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ADIE to prevent development of anxiety disorders in autism

Aligning Dimensions of Interoceptive Experience (ADIE) to prevent development of anxiety disorders in autism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14848787
Enrollment
120
Registered
2017-10-25
Start date
2017-07-10
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Mental Health, Primary sub-specialty: Developmental disorders - Autism

Interventions

Current interventions as of 11/01/2021: The first training therapy session involves a brief introduction to the intervention and reassurance that many people find the tasks challengin

Sponsors

Sussex Partnership NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026