Molehill Mountain Feasibility Study.

NCT05302167 | Completed

• 1 other identifier: 1286908
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety; Autism

Outcome Measures

Primary Outcomes (2)

• Change in 7-item Generalised Anxiety Disorder Scale (GAD-7)

  Minimum score = 0; Maximum score = 21; Higher scores indicate more severe anxiety.

  Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)

• App acceptability/ feasibility survey

  A survey developed by the investigator team to assess the acceptability and feasibility of Molehill Mountain app use by autistic adolescents/ adults in a clinically derived sample. Key indices incorporated in post-study app use experience surveys include: 1) the preparedness of participants to be randomised in a future trial; 2) ease of app administration and use; 3) preferred app features, content, and structure; 4) non-preferred app features, content, and structure; 5) experiences of app technical functionality; and 6) subjective reflections on the impact of app use on anxiety and everyday wellbeing/ functioning.

  Week 13 (+/-2)

Secondary Outcomes (2)

• Change in Medication/ service use

  Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)

• Change in Goal Attainment Scaling

  Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)

Study Arms (1)

Feasibility/ acceptability

EXPERIMENTAL

Behavioral: Molehill Mountain app; Device: Molehill Mountain app

Interventions

Molehill Mountain app BEHAVIORAL

The Molehill Mountain app (currently Version 2) was developed jointly by King's College London (Lead: Prof Emily Simonoff; Advisors: Dr Ann Ozsivadjian and Dr Rachel Kent) and UK autism charity Autistica (Product Owner: Andy Clarke; Product Designer: Joanna Alpe) for use by autistic people aged ≥12-years (https://www.autistica.org.uk/molehill-mountain). The app was designed based on a self-guided paper-and-pencil CBT toolkit adapted for autism by Professor Emily Simonoff. Since the first version of Molehill Mountain (a two-week long programme) was launched in 2016, and based on surveys of autistic people and five rounds of prototype testing, the Molehill Mountain V2 app was relaunched in April 2021 as a three-month long app-based programme with enhanced interactive features. This 3-month V2 Molehill Mountain app, with enhanced interactive features supporting short daily logins, that will be implemented in the current study.

Feasibility/ acceptability

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (2)

King's College London

London, United Kingdom

Location

South London and Maudsley NHS Foundation Trust (SLaM)

London, United Kingdom

Location

Related Publications (2)

• Oakley B, Boatman CA, Baldoza S, Hearn A, Larkworthy C, Kent R, Ozsivadjian A, Doswell S, Dittner A, Roestorf A, Rawal D, Carter B, Simonoff E; Molehill Mountain Advisory Group. Feasibility Study of a Novel App-Based Anxiety Intervention for Autistic People. Autism Res. 2025 Dec 14. doi: 10.1002/aur.70153. Online ahead of print.

  PMID: 41392571 DERIVED

• Oakley B, Boatman C, Doswell S, Dittner A, Clarke A, Ozsivadjian A, Kent R, Judd A, Baldoza S, Hearn A, Murphy D, Simonoff E; Molehill Mountain Advisory Group. Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people. PLoS One. 2023 Jul 5;18(7):e0286792. doi: 10.1371/journal.pone.0286792. eCollection 2023.

  PMID: 37406026 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Emily Simonoff, MD; PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Declan Murphy, MD; PhD

  MD; PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 31, 2022
• Study Start: September 6, 2022
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The dataset will become available at the end of the study (estimated March 2023). Due to its fully anonymised nature, this dataset will be available indefinitely.

Locations

GB (2)