Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people

This publication is included in the Autistic Autism Scholarship Project. one author of this publication is identified as autistic in the project.

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Oakley, B., Boatman, C., Doswell, S., Dittner, A., Clarke, A., Ozsivadjian, A., Kent, R., Judd, A., Baldoza, S., Hearn, A., Murphy, D., Simonoff, E., & Group, T. M. M. A. (2023). Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people. PLOS ONE, 18(7), e0286792. https://doi.org/10.1371/journal.pone.0286792

Publication date: 5 Jul 2023 Added to AutiHub: 25 Sep 2026 Type: Article Article language: English
Publisher source (DOI) Full text OpenAlex source

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Authors

Publication authors
13
Publication authors identified as autistic
1 / 13 (7.7%)
  1. Bethany Oakley
  2. Charlotte Boatman
  3. Sophie Doswell
  4. Antonia Dittner
  5. Andrew Clarke
  1. Ann Ozsivadjian
  2. Rachel Kent
  3. Adrian Judd
  4. Saffron Baldoza *
  5. Amy Hearn
  1. Declan Murphy
  2. Emily Simonoff
  3. The Molehill Mountain Advisory Group

Abstract

Up to 50% of autistic people experience co-occurring anxiety, which significantly impacts their quality of life. Consequently, developing new interventions (and/ or adapting existing ones) that improve anxiety has been indicated as a priority for clinical research and practice by the autistic community. Despite this, there are very few effective, evidence-based therapies available to autistic people that target anxiety; and those that are available (e.g., autism adapted Cognitive Behavioural Therapy; CBT) can be challenging to access. Thus, the current study will provide an early-stage proof of concept for the feasibility and acceptability of a novel app-based therapeutic approach that has been developed with, and adapted for, autistic people to support them in managing anxiety using UK National Institute for Health and Care Excellence (NICE) recommended adapted CBT approaches. This paper describes the design and methodology of an ethically approved (22/LO/0291) ongoing non-randomised pilot trial that aims to enrol approximately 100 participants aged ≥16-years with an existing autism diagnosis and mild-to-severe self-reported anxiety symptoms (trial registration NCT05302167). Participants will be invited to engage with a self-guided app-based intervention—‘Molehill Mountain’. Primary (Generalised Anxiety Disorder Assessment, Hospital Anxiety and Depression Scale) and secondary outcomes (medication/ service use and Goal Attainment Scaling) will be assessed at baseline (Week 2 +/- 2), endpoint (Week 15 +/- 2) and three follow-ups (Weeks 24, 32 and 41 +/- 4). Participants will also be invited to complete an app acceptability survey/ interview at the study endpoint. Analyses will address: 1) app acceptability/ useability and feasibility (via survey/ interview and app usage data); and 2) target population, performance of outcome measures and ideal timing/ duration of intervention (via primary/ secondary outcome measures and survey/ interview)–with both objectives further informed by a dedicated stakeholder advisory group. The evidence from this study will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, to provide a novel tool that can be accessed easily by autistic adults and may improve mental health outcomes.

Bibliography cited by this reference

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Cited bibliography overview

These indicators describe the bibliography cited by this publication. An author name is counted each time it appears in one cited reference, so the same person can be counted more than once. Names not yet linked to an author already present in AutiHub are treated as unknown, not as non-autistic. Last computed: 2 Oct 2026 01:01.

Cited references
64
With a DOI
60
Without a DOI, from raw bibliography text
4
6 / 64 (9.4%) cited references include at least one author identified as autistic.
References with data to complete
2 / 64 (3.1%)
References with detected author names
63 / 64 (98.4%)
Without detected author names
1
Without a structured title
1
Without a stable identifier
4
References with raw author names still to review
0
References with external metadata lookup issues
1
These indicators apply to cited references displayed on this page, after technical duplicates have been merged. A reference without a DOI can still support author statistics when a title and author names are available.
Author names detected in the cited bibliography
378
From DOI or external metadata
378
From validated raw bibliography text
0
Raw names already validated
0
Raw names still to review
0
204 / 378 (54.0%) names are linked to an author already present in AutiHub. 174 / 378 (46.0%) names are not yet linked.
Names linked to a person identified as autistic
18 / 378 (4.8%)
Calculated across all author names detected in the cited bibliography. Among names linked to an author already present in AutiHub: 18 / 204 (8.8%). Distinct people identified as autistic: 14 / 289 (4.8%).
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