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

NCT05376735 | Unknown

• 1 other identifier: HR/DP-21/22-28406
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety; Emotion Regulation

Keywords

emotion regulation; in-situ intervention; university students

Outcome Measures

Primary Outcomes (2)

• Anxiety (measured by GAD7) -- pre/mid/post

  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.

  Three times during the 4-week long deployment period: pre, mid and post deployment

• Anxiety (measured by GAD2) -- weekly

  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.

  Once a week for the 4-week long deployment period

Secondary Outcomes (10)

• Depression -- pre/mid/post

  Three times during the 4-week long deployment period: pre, mid and post deployment

• Depression -- weekly

  Once a week for the 4-week long deployment period

• Emotion regulation (beliefs ) -- pre/mid/post

  Three times during the 4-week long deployment period: pre, mid and post deployment

• 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 - open ended

  Once a week for the 4-week long deployment period

Study Arms (2)

Purrble intervention + Single Session Intervention

EXPERIMENTAL

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.

Behavioral: Purrble intervention; Behavioral: Single Session Intervention

Treatment as usual / Waiting list

NO INTERVENTION

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.

Interventions

Purrble intervention BEHAVIORAL

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.

Purrble intervention + Single Session Intervention

Single Session Intervention BEHAVIORAL

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.

Also known as: SSI

Purrble intervention + Single Session Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• University of Oxford: collaborator
• Stony Brook University: collaborator
• Stanford University: collaborator

Related Publications (9)

• 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.

  PMID: 30211576 BACKGROUND

• 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.

  PMID: 29871870 BACKGROUND

• 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.

  PMID: 29768071 BACKGROUND

• 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.

  PMID: 24725765 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 22582765 BACKGROUND

• 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.

  PMID: 29620380 BACKGROUND

• 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.

  PMID: 33021487 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Petr Slovak, Dr

CONTACT

+44 020 7848 1988; petr.slovak@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 17, 2022
• Study Start: May 16, 2022
• Primary Completion: July 17, 2022
• Study Completion: September 19, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share