UnknownNot Applicable

Randomised Control Trial of an Intervention to Promote Emotion Regulation Strategies in University Students

100 participantsStarted 2022-05-16

Plain-language summary

The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) and a bespoke Single Session Intervention (SSI) on students' anxiety (measured by GAD7) over the period of the academic term (in comparison to a wait-listed student group). Secondary aims include investigating the effects of the Purrble and SSI on students' depression, emotion regulation processes, and quantitative and qualitative (interviews) measures of engagement with the intervention.

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Currently registered as a student at Oxford University (under- or postgraduate) at the time of the study * Currently living in the UK at the time of the study * Aged 18-25 * GAD7 score \>= 10 (Löwe, 2008) * Consistent internet and computer/laptop/smartphone access * Able to read and write in English Exclusion Criteria: * Not an Oxford University student currently living in the UK at the time of the study * Not within age range * GAD7 score \< 10 (Löwe, 2008)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety (measured by GAD7) -- pre/mid/post

Timeframe: Three times during the 4-week long deployment period: pre, mid and post deployment

Anxiety (measured by GAD2) -- weekly

Timeframe: Once a week for the 4-week long deployment period

Trial details

NCT IDNCT05376735

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-17

Contact for this trial

Petr Slovak, Dr

+44 020 7848 1988 petr.slovak@kcl.ac.uk

View on ClinicalTrials.gov More Anxiety trials