Clinical trial NCT05376735: Randomised Control Trial of an Intervention to Promote Emotion Regulation Strategies in University Students
Official title: An Exploratory Randomised Control Trial of a Single Session Intervention Combined With In-situ Socially Assistive Robot to Promote Emotion Regulation Competence in University Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Emotion Regulation
Keywords: emotion regulation
in-situ intervention
university students
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Stony Brook University
name: Stanford University
First posted: 2022-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Need among college students for accessible mental health support is high: for example, the WHO World Mental Health International College Student project,(Auerbach et al., 2018) 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 counseling on many campuses being weeks to months long (cf., for example Brown 2018). 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 (Torous et al, 2018), 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 (Musiat et al, 2014).

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.

Eligibility criteria: 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 18-25
* GAD7 score \>= 10 (Löwe, 2008)
* 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 \< 10 (Löwe, 2008)

Primary outcomes:
measure: Anxiety (measured by GAD7) -- pre/mid/post
timeFrame: Three times during the 4-week long deployment period: pre, mid and post deployment
measure: Anxiety (measured by GAD2) -- weekly
timeFrame: Once a week for the 4-week long deployment period
Secondary outcomes:
measure: Depression -- pre/mid/post
timeFrame: Three times during the 4-week long deployment period: pre, mid and post deployment
measure: Depression -- weekly
timeFrame: Once a week for the 4-week long deployment period
measure: Emotion regulation (beliefs ) -- pre/mid/post
timeFrame: Three times during the 4-week long deployment period: pre, mid and post deployment
measure: Emotion regulation (self-efficacy) -- pre/mid/post
timeFrame: Three times during the 4-week long deployment period: pre, mid and post deployment
measure: Engagement with the Purrble intervention - open ended
timeFrame: Once a week for the 4-week long deployment period
measure: Engagement with the Purrble intervention - TWEETS
timeFrame: week 2 and week 4 of the active deployment phase
measure: Engagement with the Single Session Intervention
timeFrame: Once after completing the online SSI programme (week 1)
measure: Hopefulness -- weekly
timeFrame: Once a week for the 4-week long deployment period
measure: Hopelesness -- weekly
timeFrame: Once a week for the 4-week long deployment period
measure: Emotion regulation -- weekly
timeFrame: Once a week for the 4-week long deployment period
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.