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

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.

Conditions

• Anxiety
• Emotion Regulation

Interventions

BEHAVIORAL

Purrble intervention

The intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing. The Purrble is introduced to the student as an anxious creature that may need kind attention from humans. When picked up, the Purrble emits a frantic heartbeat that slows down if the child uses calm stroking movements. If it's soothed for long enough, it transitions into a purring vibration indicating a calm, content state. Logic model underlying the intervention: Level 1: in-the-moment soothing support to students in emotional moments when they would attempt to practice emotion regulation (ER) strategies to calm down. Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1. Level 3: shift in students' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2.

BEHAVIORAL

Single Session Intervention

The SSI has been co-produced with university students and clinical experts, combining the theories of ER with the qualitative experiences of students in open trial. The result follows a traditional SSI structure (cf., Schleider et al 2020), including * Initial guided reflection exercise (helping understand one's experience with Purrble in the 1st week). * Short interactive psychoeducation, introducing the concept of window of tolerance, the Process Model of Emotions (Gross2015), and specific ways in which Purrble can help students down-regulate emotions within the context of the process model. * Action plan to identify: moments when Purrble could be useful, what ER strategies they would like to use in those moments, what obstacles they may encounter, and how to overcome them. The SSI will be accessible by students on a website and be both desktop and mobile browser friendly. The full process should not take students longer than 30 minutes.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• Stony Brook University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• King's College London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-16

Primary Completion

2022-07-17

Completion

2022-09-19