Randomised Control Trial of an Intervention to Promote Emotion Regulation Strategies in University Students
NCT ID: NCT05376735
Last Updated: 2022-05-27
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-05-16
2022-09-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Purrble intervention + Single Session Intervention
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.
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.
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.
Treatment as usual / Waiting list
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.
No interventions assigned to this group
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 within age range
* GAD7 score \< 10 (Löwe, 2008)
18 Years
25 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Stony Brook University
OTHER
Stanford University
OTHER
King's College London
OTHER
Responsible Party
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Central Contacts
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References
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Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.
Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116-119. doi: 10.1136/eb-2018-102891. Epub 2018 Jun 5.
Brown JSL. Student mental health: some answers and more questions. J Ment Health. 2018 Jun;27(3):193-196. doi: 10.1080/09638237.2018.1470319. Epub 2018 May 16. No abstract available.
Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Goldin PR, Ziv M, Jazaieri H, Werner K, Kraemer H, Heimberg RG, Gross JJ. Cognitive reappraisal self-efficacy mediates the effects of individual cognitive-behavioral therapy for social anxiety disorder. J Consult Clin Psychol. 2012 Dec;80(6):1034-40. doi: 10.1037/a0028555. Epub 2012 May 14.
Ford BQ, Lwi SJ, Gentzler AL, Hankin B, Mauss IB. The cost of believing emotions are uncontrollable: Youths' beliefs about emotion predict emotion regulation and depressive symptoms. J Exp Psychol Gen. 2018 Aug;147(8):1170-1190. doi: 10.1037/xge0000396. Epub 2018 Apr 5.
Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HR/DP-21/22-28406
Identifier Type: -
Identifier Source: org_study_id
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