AnxietyNCT05302167
Molehill Mountain Feasibility Study.
A study testing Molehill Mountain app in people with Anxiety and Autism, run by King's College London at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Molehill Mountain app
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Sep 2022to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
King's College London
London
South London and Maudsley NHS Foundation Trust (SLaM)
London
About this study
Official title: Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.
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.
- Being tested
- Molehill Mountain app
- Medical subject headings
- Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molehill Mountain appBehavioural
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.
Molehill Mountain appDevice
As above.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility/ acceptability | Experimental | Not described Receives: Behavioral: Molehill Mountain app; Device: Molehill Mountain app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 7-item Generalised Anxiety Disorder Scale (GAD-7)
Minimum score = 0; Maximum score = 21; Higher scores indicate more severe anxiety.
Measured: 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.
Measured: Week 13 (+/-2)
Secondary outcomes (2)
Change in Medication/ service use
To indicate changes in medication (number of medications, dose, frequency) and/ or clinical service use (number of appointments, attendance, length of engagement with services) with using the Molehill Mountain app to manage anxiety.
Measured: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Change in Goal Attainment Scaling
Participants will choose 3 priority goals from a list of functional outcomes, including feeling less anxious, understanding anxiety better, understanding anxiety triggers better, and reducing anxiety across key areas of everyday life (e.g., relationships, social encounters, communication, school/ work, leisure, sensory). Participants will rate their progress in relation to these 3 goals on a scale from 1 (a very long way from this goal) to 7 (achieved this goal).
Measured: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start6 Sep 2022
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Emily Simonoff, MD; PhD, Principal investigator, King's College LondonDeclan Murphy, MD; PhD, Principal investigator, MD; PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302167
- Sponsor's protocol ID
- 1286908
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will produce a fully anonymised (i.e., no longer coded, or including any identifiable or special category data) quantitative dataset at the end of the study that will be openly accessible. Participant consent will be gained to do so.
Publications
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. 2026 Jan;19(1):e70153. doi: 10.1002/aur.70153. Epub 2025 Dec 14.
PubMed 41392571Oakley 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.
PubMed 37406026
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.
- ClinicalTrials.gov ID
- NCT05302167
- Acronym / sponsor ID
- 1286908
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility/ acceptability | Experimental | Behavioral: Molehill Mountain app, Device: Molehill Mountain app |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molehill Mountain appThe 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. | Behavioural | Feasibility/ acceptability |
| Molehill Mountain appAs above. | Device | Feasibility/ acceptability |
Primary outcome
Change in 7-item Generalised Anxiety Disorder Scale (GAD-7)
Time frame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Minimum score = 0; Maximum score = 21; Higher scores indicate more severe anxiety.
App acceptability/ feasibility survey
Time frame: Week 13 (+/-2)
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.
2 secondary outcomes
Change in Medication/ service use
Time frame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Change in Goal Attainment Scaling
Time frame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 41392571Oakley 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. 2026 Jan;19(1):e70153. doi: 10.1002/aur.70153. Epub 2025 Dec 14.
- Derived from this study: PubMed 37406026Oakley 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.
- Individual participant dataSharing planned: Yes. The research team will produce a fully anonymised (i.e., no longer coded, or including any identifiable or special category data) quantitative dataset at the end of the study that will be openly accessible. Participant consent will be gained to do so.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Simonoff, MD; PhD principal investigator
King's College London
Declan Murphy, MD; PhD principal investigator
MD; PhD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molehill Mountain app in people with Anxiety and Autism, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 7-item Generalised Anxiety Disorder Scale (GAD-7) (time frame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.