Molehill Mountain Feasibility Study.

King's College London

Status

Completed

Conditions

Anxiety

Autism

Treatments

Device: Molehill Mountain app

Study type

Interventional

Funder types

Other

Identifiers

NCT05302167

1286908

Details and patient eligibility

About

Up to half of autistic people experience anxiety symptoms, which can have a significant impact on everyday wellbeing. However, there are currently very few effective, evidence-based interventions to support autistic people in managing anxiety; and many autistic people face barriers in accessing inperson health and social care services. Therefore, developing new interventions (and/ or adapting existing ones) that improve anxiety, in a way that meets the needs of autistic people, represents the autism community's number one priority for research and clinical practice.

Addressing this priority, the investigators will test the acceptability and feasibility of a new, app-based therapeutic approach for anxiety ('Molehill Mountain') that has been developed with, and adapted for, autistic people aged 12-years and over using adapted Cognitive Behavioural therapy principles. This means that information will be collected from autistic people accessing clinical services on whether they would choose to use the anxiety app, whether the app is simple to administer and use, how it is used, how it can be improved, and whether it is effective in reducing anxiety symptoms and/ or enhancing other outcomes, such as everyday wellbeing and functioning.

The evidence from this project will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, with the ultimate aim of transforming long-term healthcare delivery for autistic people.

Enrollment

100 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.