Intervention Package to Promote Emotion Regulation Strategies in University Students
NCT ID: NCT05701670
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
191 participants
INTERVENTIONAL
2023-01-30
2023-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomised Control Trial of an Intervention to Promote Emotion Regulation Strategies in University Students
NCT05376735
Online Cognitive Behavioral Intervention Program for Hong Kong University Students
NCT04389242
Chatbot-based Mindfulness Programme for Depressive University Students: Pilot Intervention Study
NCT06440941
A Single-Session Intervention Fostering Emotional Nonreactivity
NCT07034027
Cognitive Mindfulness Intervention Using Virtual Reality to Address Academic Procrastination and Academic Engagement
NCT06664346
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
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.
Purrble+SSI
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.
Control
Wait-list control (access to services as usual)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Purrble+SSI
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 within age range
* GAD7 score of under 10
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Stony Brook University
OTHER
Stanford University
OTHER
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King's College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Beck, A. T., Steer, R. A., & Pompili, M. (1988). BHS, Beck hopelessness scale: manual. San Antonio, TX: Psychological corporation.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RESCM-22/23-28406
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.