Intervention Package to Promote Emotion Regulation Strategies in University Students

NCT05701670 | Completed DMC

• 1 other identifier: RESCM-22/23-28406
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anxiety; Emotion Regulation

Keywords

emotion regulation; anxiety; students; intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Depression (PHQ-9)

  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)

  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)

  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

  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

  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

Study Arms (2)

Intervention

EXPERIMENTAL

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 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+SSI

Control

NO INTERVENTION

Wait-list control (access to services as usual)

Interventions

Purrble+SSI BEHAVIORAL

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.

Also known as: Purrble intervention + Single Session Intervention

Intervention

Eligibility Criteria

• Age: 18 Years - 30 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 18-30
• GAD7 score of 10 or above.
• 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 of under 10

Sponsors & Collaborators

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

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (13)

• 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

• 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

• 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

• Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.

  PMID: 31290406 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

• 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

• 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

• Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.

  PMID: 8636885 BACKGROUND

• Daudén Roquet, C., Theofanopoulou, N., Freeman, J. L., Schleider, J., Gross, J. J., Davis, K., ... & Slovak, P. (2022, April). Exploring Situated & Embodied Support for Youth's Mental Health: Design Opportunities for Interactive Tangible Device. In Proceedings of the 2022 CHI Conference on Human Factors in Computing Systems (pp. 1-16).

  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

• Beck, A. T., Steer, R. A., & Pompili, M. (1988). BHS, Beck hopelessness scale: manual. San Antonio, TX: Psychological corporation.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

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: January 13, 2023
• First Posted: January 27, 2023
• Study Start: January 30, 2023
• Primary Completion: June 17, 2023
• Study Completion: August 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-01

Locations

GB (1)