NCT05302167Completed
Molehill Mountain Feasibility Study.
Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.
Source: ClinicalTrials.gov · Last updated 26 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 4 Feb 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 24 Oct 2024
- Lead sponsor
- King's College London
- Diseases
- Autism
- NCT number
- NCT05302167
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 6 Sept 2022 to the primary completion date, 24 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South London and Maudsley NHS Foundation Trust (SLaM) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
Related publications
- Feasibility Study of a Novel App-Based Anxiety Intervention for Autistic People.Autism Res · 2026 · PMID 41392571
This page is information, not medical advice. Discuss any trial with your doctor.