Molehill Mountain Feasibility Study.
- Conditions
- AutismAnxiety
- Interventions
- Device: Molehill Mountain app
- Registration Number
- NCT05302167
- Lead Sponsor
- King's College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Feasibility/ acceptability Molehill Mountain app -
- Primary Outcome Measures
Name Time Method App acceptability/ feasibility survey 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.
Change in 7-item Generalised Anxiety Disorder Scale (GAD-7) 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.
- Secondary Outcome Measures
Name Time Method Change in Medication/ service use Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4) 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.
Change in Goal Attainment Scaling Week 0 (+/-2); Week 13 (+/-2); Week 24 (+/- 4); Week 32 (+/-4); Week 41 (+/-4) 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).
Trial Locations
- Locations (2)
South London and Maudsley NHS Foundation Trust (SLaM)
🇬🇧London, United Kingdom
King's College London
🇬🇧London, United Kingdom