Clinical trial NCT05701670: Intervention Package to Promote Emotion Regulation Strategies in University Students
Official title: A Randomised Control Trial Investigating the Effects of Purrble and a Single Session Intervention on Emotional Regulation and Anxiety Among Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Emotion Regulation
Keywords: emotion regulation
anxiety
students
intervention
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Stony Brook University
name: Stanford University
First posted: 2023-01-27
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
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 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.

Detailed description: Need among college students for accessible mental health support is high: for example, the WHO World Mental Health International College Student project 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 counselling on many campuses being weeks to months long. 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, 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.

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.

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 18-30
* GAD7 score of 10 or above.
* 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 of under 10

Primary outcomes:
measure: Anxiety (GAD-7)
timeFrame: 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:
measure: Depression (PHQ-9)
timeFrame: 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
measure: Emotion regulation (beliefs)
timeFrame: 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
measure: Emotion regulation (self-efficacy)
timeFrame: 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
measure: Hopefulness
timeFrame: 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
measure: Hopelessness
timeFrame: 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
measure: Engagement with the Purrble intervention
timeFrame: 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 7 times
measure: Engagement with the Purrble intervention (TWEETS)
timeFrame: 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 7 times
measure: Engagement with the Single Session Intervention
timeFrame: Once after completing the online SSI programme (week 1)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
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