An Exploratory Randomised Control Trial of a Single Session Intervention Combined With In-situ Socially Assistive Robot to Promote Emotion Regulation Competence in University Students
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- King's College London
- Enrollment
- 100
- Primary Endpoint
- Anxiety (measured by GAD7) -- pre/mid/post
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Anxiety (measured by GAD7) -- pre/mid/post
Time Frame: Three times during the 4-week long deployment period: pre, mid and post deployment
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group). Overall changes in anxiety throughout the deployment will be measured by the Generalised Anxiety Disorder Assessment (GAD-7), a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks (Splitzer et al 2006). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Anxiety (measured by GAD2) -- weekly
Time Frame: Once a week for the 4-week long deployment period
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group). Weekly changes in anxiety will be measured with the Generalized Anxiety Disorder 2-item (GAD-2): a very brief and easy to perform initial screening tool for generalized anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks (Kroenke et al 2007). A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted. Using a cut-off of 3 the GAD-2 has a sensitivity of 86% and specificity of 83% for diagnosis generalized anxiety disorder.
Secondary Outcomes
- Emotion regulation (beliefs ) -- pre/mid/post(Three times during the 4-week long deployment period: pre, mid and post deployment)
- Engagement with the Purrble intervention - open ended(Once a week for the 4-week long deployment period)
- Hopefulness -- weekly(Once a week for the 4-week long deployment period)
- Hopelesness -- weekly(Once a week for the 4-week long deployment period)
- Emotion regulation (self-efficacy) -- pre/mid/post(Three times during the 4-week long deployment period: pre, mid and post deployment)
- Engagement with the Purrble intervention - TWEETS(week 2 and week 4 of the active deployment phase)
- Emotion regulation -- weekly(Once a week for the 4-week long deployment period)
- Depression -- weekly(Once a week for the 4-week long deployment period)
- Depression -- pre/mid/post(Three times during the 4-week long deployment period: pre, mid and post deployment)
- Engagement with the Single Session Intervention(Once after completing the online SSI programme (week 1))