Intervention Package to Promote Emotion Regulation Strategies in University Students

Study Overview
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Brief Summary
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The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) and a co-designed, bespoke Single Session Intervention (SSI) on students' anxiety (GAD-7) over the period of the two academic terms (in comparison to a wait-listed student group). Secondary aims include investigating the effects of the Purrble and SSI on students' emotion regulation processes, depressive symptoms, and quantitative and qualitative (interviews) measures of engagement with the intervention.

Detailed Description
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Need among college students for accessible mental health support is high: for example, the WHO World Mental Health International College Student project 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 counselling on many campuses being weeks to months long. 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, 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. Thus, there 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 initial pilot work (n=80, open trial at Oxford) the investigators evaluated one such possible tool, Purble, 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 (GAD7 > 10 at sign-up). The results have been promising, with large pre-/post- effects sizes on GAD-7 scores over the period of the term. Moreover, the majority of students perceived the Purrble intervention as useful (with 61% reporting in the last survey that it helped their mental health) and have reported 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 to 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 wait-listed group and thus more rigorous investigation of these promising effects is needed. In an prior unpowered pilot RCT, we tested the procedures that are to be used within this proposed study.

Official Title
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A Randomised Control Trial Investigating the Effects of Purrble and a Single Session Intervention on Emotional Regulation and Anxiety Among Students

Conditions
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Anxiety, Emotion Regulation

Intervention / Treatment
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* Behavioral: Purrble+SSI


Participation Criteria
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Eligibility Criteria
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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 18-30 GAD7 score of 10 or above. 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 of under 10

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the student and support in-the-moment soothing -- see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914) The Single Session Intervention has been co-produced with university students and clinical experts (Prof Jessica Schleider and Prof James Gross), 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 Initial guided reflection exercise Short interactive psychoeducation 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. | Behavioral: Purrble+SSI<br>* Purrble intervention as described above. Single Session Intervention (SSI) ( 30mins) combining the theories of ER with the experiences from students involved in previous studies, and follows a traditional SSI structure (Schleider et al 2020). Specific content has been co-produced with students and experts.<br>* Other names: Purrble intervention + Single Session Intervention;|
| No Intervention: Control<br>Wait-list control (access to services as usual) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (GAD-7) | 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). Measured by: 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 (score range from 0-21). 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. | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression (PHQ-9) | Based on the findings from the pilot RCT, the Patient Health Questionnaire-9 (Kroenke et al., 2001) has been included as a key secondary measure. The aim being to investigate the effects of Purrble + SSI intervention on changes in students' depression over the period of academic term (in comparison to a wait-listed student group). Measured by: PHQ-9, a depression module which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. The maximum score is 27 (9 questions x maximum 3 points per question). Depression severity is graded based on the PHQ-9 score: None 0-4 Mild 5-9 Moderately 10-14 Moderately severe 15-19 Severe 20-27 | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 
| Emotion regulation (beliefs) | A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' emotion regulation processes over the period of academic term (in comparison to a wait-listed student group). Student-reported beliefs about emotion regulation will be measured by the Emotion Regulation Beliefs questionnaire (Ford et al., 2018). Specifically, students will answer 4 questions on a five point Likert scale (strongly disagree --> strongly agree), which ask about incremental and entity beliefs. Incremental belief items are reverse-scored. Score range from 4-20, higher scores across beliefs indicated holding entity beliefs, while lower scores are interpreted as incremental beliefs. | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 
| Emotion regulation (self-efficacy) | A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' emotion regulation processes over the period of two academic terms (in comparison to a wait-listed student group). Student-reported capability of regulating / managing own emotion will be measured by the Self-Efficacy version of the Emotion Regulation Questionnaire (ERQ-SE; Goldin et al., 2012).The ERQ-SE score is calculated by assigning scores from 1 (strongly disagree) to 7 (strongly agree), 4 being considered neutral. Ratings are calculated for a total self-efficacy score (10-70), with higher scores indicating better capability to manage one's emotions. | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 
| Hopefulness | A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' depression over the two academic terms (in comparison to a wait-listed student group). Measured by: The State Hope Scale (Snyder et al., 1996) is a 6-item self-report measure of ongoing goal-directed thinking (agency and pathways). Responses are rated on an 8-point Likert scale ranging from 1 (Definitely True) to 8 (Definitely False) with higher scores indicative of greater state hopefulness (total score: 6-48). | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 
| Hopelessness | A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' depression over the two academic terms (in comparison to a wait-listed student group). Measured by: The Beck Hopelessness Scale (Beck, 1988) provides a self-report measure of one's negative expectations regarding the future. It consists of 20 true-false items arrayed within three factors: Feelings about the future, loss of motivation, and future expectations. The total score is a sum of item responses. Scores ranging from: 0 to 3 within the normal range, 4 to 8 mild hopelessness, 9 to 14 moderate hopelessness, and scores greater than 14 identify severe hopelessness. | Once at baseline (wk0). Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 8 times | 
| Engagement with the Purrble intervention | A secondary aim includes investigating the engagements with the Purrble + SSI intervention over the two academic terms. Measured by: A bespoke survey informed by the pilot study (Dauden Roquet et al., 2022). The questions inquire about Purrble use and perceived usefulness. Items are rated on a 0 to 4 scale unless otherwise specified, and will be analysed separately. How often did participants engage with Purrble this week? If not at all, why do participants think that was? On average, did engaging with Purrble make any difference to how participants felt at the time? | Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 7 times | 
| Engagement with the Purrble intervention (TWEETS) | A secondary aim includes investigating the engagements with the Purrble + SSI intervention over the two academic terms. Measured by: An adapted version of Twente Engagement with eHealth Technologies Scale (TWEETS; Kelders et al., 2020). Consisting of 9-items measured on a 5-point Likert scale ranging from strongly disagree (0) to strongly agree (4), total score ranging from 0-36. Engagement is split into subsections considering behaviour, cognitive and affective engagement. Higher scores indicate greater engagement with the intervention. | Four times during the 4-week long deployment period (wk1, wk2, wk3, wk4); and then once a month up until the 3-month follow-up (wk8, wk12, wk4) = total of 7 times | 
| Engagement with the Single Session Intervention | Measured by: A program feedback scale (Schleider et al., 2019) was adapted for this study. Items rated on a 1 (really disagree) to 5 (really agree) scale unless otherwise specified. Each item can be analysed separately and as a mean score across items the 7 quantitative items, total score ranges from 7-45. I enjoyed the program I understood the program This program was easy to use I tried my hardest during the program I think the program would be helpful to other university students I would recommend this program to a friend going through a hard time I agree with the program's message What did participants like about the program? Please share as many true thoughts and feelings as participants would like << open-ended, text area >> What would participants change about the program? Please share as many true thoughts and feelings as participants would like << open-ended, text area >> | Once after completing the online SSI programme (week 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotion regulation, anxiety, students, intervention