Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT05302167
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 16-years.
* Autism diagnosis.
* Current mild-to-severe anxiety symptom severity, as assessed at screening (and currently in touch with mental health services e.g., referred, on the waitlist).
* Able and willing to provide verbal and written informed consent to take part in the study.
* Access to Molehill Mountain app via SmartPhone or other Smart device.
Exclusion Criteria:
* Difficulties with reading/ writing to the extent that the app is inaccessible.
* High risk of self-harm that make participation in the study inappropriate for the individual's current level of clinical need (as assessed by clinical team).
* Attended ≥ 6 sessions of individual or group therapy (e.g., cognitive behavioural therapy) in the past 6-months, which would make it impossible to parse out the effects of the app from existing therapy.
* If using psychotropic medication, this medication/ dose must have been stable for a minimum of 8-weeks on entry to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05302167
Study Brief:
Protocol Section:
NCT05302167