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

King's College London

Status: Unknown

Conditions: Emotion Regulation; Anxiety

Treatments: Behavioral: Purrble intervention; Behavioral: Single Session Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05376735

HR/DP-21/22-28406

Details and patient eligibility

About

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.

Full description

Need among college students for accessible mental health support is high: for example, the WHO World Mental Health International College Student project,(Auerbach et al., 2018) involving 13,984 first-year college students from eight countries, found that 31% of the respondents screened positive for depression, anxiety, or alcohol use disorder. Yet, access to professional support has long remained low, with waitlists for counseling on many campuses being weeks to months long (cf., for example Brown 2018). Digital technologies, including apps, have been proposed as one possible means of 'filling in the gaps' in extant mental health care support for college students - but most apps suffer from low usability in real-world settings (Torous et al, 2018), are not equipped to serve in-the-moment coping needs (e.g., they involve user-initiated psychoeducation modules rather than opportunities to practice and grow skills when they are needed most) and often show high drop-out rates (Musiat et al, 2014).

There thus is a clear need to harness digital technologies to create usable, engaging, evidence-supported mental health supports that may be used flexibly based on when students need them most (e.g. when stress levels are particularly high and coping skills most warrant deployment); ideally also as an adjunct completing existing counselling service.

In the pilot work last year (n=80, open trial at Oxford) the investigators evaluated one such possible tool-Purrble-designed to provide a student-centred, in-the-moment emotion regulation support. Study goals centred on testing usability/usage patterns during 8-week in-situ deployment, perceived usefulness over the same period, and links between use and symptoms in high-anxiety university students (GAD-7 > 10 at sign-up). The results have been promising, with large effects sizes on GAD7 scores over the period of the term (d~0.9), the majority of students perceived the Purrble intervention as useful with 61% reporting in the last survey that it helped their mental health, and detailed a range of positive outcomes in qualitative interviews (e.g., it helped them calm down and ground themselves in the present moment when they are feeling anxious, stressed or lonely, or be more gentle and kind with themselves -rather than harsh and judgmental- when feeling overwhelmed).

However, the open trial pilot study did not include a control or waitlisted group and thus more rigorous investigation of these promising effects is needed - leading to the current study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Purrble intervention + Single Session Intervention

Experimental group

Description:

The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing. When the Purrble is picked up, it emits a frantic heartbeat that slows down if the person uses calm stroking movements. If the Purrble is soothed for long enough, it transitions into a purring vibration indicating a calm, content state. The Single Session Intervention has been co-produced with university students and clinical experts (Prof Jessica Schleider), combining the theories of emotion regulation with the qualitative experiences of students in open trial. The result follows a traditional SSI structure (cf., Schleider et al 2020), including 1. Initial guided reflection exercise 2. Short interactive psychoeducation 3. Personalised action plan 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.

Treatment:

Behavioral: Single Session Intervention

Behavioral: Purrble intervention

Treatment as usual / Waiting list

No Intervention group

Description:

Participants in the control group will be given a Purrble \& access to the online SSI intervention before the academic term ends, after 4 week follow-up questionnaires are completed.