Clinical trial NCT05302167: Molehill Mountain Feasibility Study.
Official title: Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Autism
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in 7-item Generalised Anxiety Disorder Scale (GAD-7)
timeFrame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
measure: App acceptability/ feasibility survey
timeFrame: Week 13 (+/-2)
Secondary outcomes:
measure: Change in Medication/ service use
timeFrame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
measure: Change in Goal Attainment Scaling
timeFrame: Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust (SLaM)
Study officials:
affiliation: King's College London
name: Emily Simonoff, MD; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD; PhD
name: Declan Murphy, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: