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Trial registered on ANZCTR


Registration number
ACTRN12622000181707
Ethics application status
Approved
Date submitted
20/01/2022
Date registered
2/02/2022
Date last updated
23/11/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial (RCT) of Managing Emotion in First Year University Students: An Online Emotion Regulation Skills Program for University Students
Scientific title
Randomised Controlled Trial (RCT) of Managing Emotion in First Year University Students: Efficacy of an Online Emotion Regulation Skills Program for University Students
Secondary ID [1] 306214 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
We previously conducted an open-label study for initial evaluation of our emotion regulation intervention (i.e. ACTRN12620000390987), and a pilot randomised controlled trial to evaluate this intervention with active treatment vs wait-list control conditions (i.e. ACTRN12620000839909).

Health condition
Health condition(s) or problem(s) studied:
Emotion dysregulation 324927 0
Condition category
Condition code
Mental Health 322361 322361 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Managing Emotion is a brief online psychoeducation program designed to support the psychological and emotional well-being of university students. The psychoeducation content of Managing Emotion draws from the seminal Process Model of Emotion Regulation (Gross, 1998; 2015), which provides an overarching framework for understanding the experience of emotion, and how we can change our emotional states via a number of cognitive and behavioural strategies. Intervention content has been developed by the investigators who are researchers within the School of Psychology, Curtin University, with a demonstrated track record in emotion regulation and related fields. Peer consultation was further sought with clinical psychologists within Western Australia.

Managing Emotion consists of five online modules which progressively introduce and discuss strategies for regulating emotion. Psychoeducation content is delivered via a series of short engaging videos, with an accompanying written summary of the video content. At the end of each module, participants are also provided with a module worksheet, which includes some simple take-home activities designed to facilitate processing of the intervention content. These worksheets have been designed to help personalise the intervention content for each participant’s individual life circumstances and concerns.

Participants complete the online intervention modules individually, at their own pace, with each module typically requiring between 20 to 30 minutes to complete. The intervention has been designed to be delivered sequentially, as each module builds upon the content of previous modules. Participants are advised of this and encouraged to complete the entire Managing Emotion program (including take-home worksheets) spread over the course of one week, in sequential order with each module completed once.

It is noted that although we encourage participants to complete the intervention in the aforementioned way, we have opted to not implement “forced” participant responses. It will be technically possible for participants to either skip modules or worksheets, or to view the modules out of sequence, or to view one module multiple times. We will be collecting basic time-stamped usage statistics in order to assess participant compliance, which in turn will help inform the fidelity of the intervention delivery for future revision.

For this study, participants will be randomly assigned to either receive the Managing Emotion intervention or treatment as usual (i.e. provided with a list of general mental health resources).
Intervention code [1] 322617 0
Behaviour
Intervention code [2] 322618 0
Prevention
Comparator / control treatment
This study includes a treatment as usual control group (i.e. provided with a list of general mental health resources). Participants who are randomly assigned to this group will be asked to complete the set of questionnaire assessment measures across three timepoints (pre and post measures one week apart, and at one month follow-up). Following this, control participants will have to opportunity to access the same intervention content which was provided to participants in the active treatment group.
Control group
Active

Outcomes
Primary outcome [1] 330130 0
Emotion Regulation Questionnaire (ERQ; Gross & John, 2003) – A 10-item self-report measure of how an individual regulates their emotional experience and expression. Two regulation strategies, cognitive reappraisal and expressive suppression, are assessed.

Questionnaire-based assessment measures will be completed immediately before and after intervention, as well as following the end of each module, and at one month follow-up. This study will be conducted entirely online.
Timepoint [1] 330130 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment (primary timepoint).
Primary outcome [2] 330131 0
Regulatory Emotional Self-Efficacy Scale (RESE; Capara et al, 2008) – a 12-item self-report assessment of perceived self-efficacy in managing negative affect and expressing positive affect.
Timepoint [2] 330131 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment (primary timepoint).
Primary outcome [3] 330132 0
Depression Anxiety Stress Scale (Lovibond & Lovibond, 1995) – A widely used 21-item self-report assessment of depression, anxiety, and stress.
Timepoint [3] 330132 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment (primary timepoint).
Secondary outcome [1] 404976 0
Difficulties in Emotion Regulation Scale – Short Form (DERS-SF; Victor & Klonsky, 2016) – an 18-item self-report measure of emotion regulation ability
Timepoint [1] 404976 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment.
Secondary outcome [2] 404977 0
Self-Compassion Scale (Raes et al, 2011) – A 12-item measure of self-compassion via attitudes and behaviours directed towards oneself during emotionally difficult times.
Timepoint [2] 404977 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment.
Secondary outcome [3] 404978 0
Brief Resilience Scale (Smith et al, 2008) – A 6-item self-report measure of the ability to recover from stress.
Timepoint [3] 404978 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment.
Secondary outcome [4] 404979 0
Inventory of Statements About Self-Injury (ISAS; Klonsky & Olino, 2008) – a comprehensive self-report assessment of non-suicidal self-injury
Timepoint [4] 404979 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment.
Note: only participants who report past or present self-injuring (item 1) are required to complete the ISAS
Secondary outcome [5] 404980 0
Satisfaction with Life Scale (Diener et al., 1985) which provides a brief 5-item assessment of overall quality of life.
Timepoint [5] 404980 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
iii. Follow-up: 1 month following post-intervention assessment.
Secondary outcome [6] 405153 0
Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) – a 6-item self-report scale for measuring participant views on treatment expectancy and rationale credibility for clinical outcome studies.
Timepoint [6] 405153 0
i. Immediately following completion of each module
Secondary outcome [7] 405154 0
Academic outcomes: Participants’ university administrative records and grades (i.e. course weighted average, course, unit retention information, and demographic data) will be linked to the questionnaire data collected as part of the present study.

Note: Consent to access these university records will be completely voluntary and provided separately to the consent to participate in the present study. In other words, students will still be able to participate in this study, if they do not consent to us accessing their university records.
Timepoint [7] 405154 0
i. 6 to 12 months following post-intervention assessment (i.e. at end of the academic semester or year)

Eligibility
Key inclusion criteria
First year university students
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Students who have already completed the Managing Emotion intervention as part of the open-label pilot study (Trial ID: ACTRN12620000390987) or pilot randomised controlled trial (Trial ID: ACTRN12620000839909)
- Students identified as being at moderate (suicidal ideation in last 12 months) to high suicide risk (suicide attempt in last 12 months, or high future suicide risk as identified by algorithm) via a mental health screening survey (i.e. Curtin Wellbeing Survey).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer-generated randomizer function in Qualtrics Survey software platform
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our initial open-label pilot data suggests that the intervention may be associated with small-to-medium effect changes in emotion symptoms, as measured by the depression, anxiety and stress sub-scales of the DASS. Assuming a small-medium effect size, with an alpha of 0.05, and power of 0.8, a minimum of 70 participants is required.

Participants will be recruited for the trial through the Curtin Wellbeing Survey, a mental health screening and stepped referral care program offered to all first year students at Curtin University in Western Australia. Students identified as being at low suicide risk will be invited to participate in the Managing Emotion RCT. On average, approximately 5,000 first-year students commence studies at Curtin each year. Of these, we anticipate that up to 50% will complete the survey each year. Based on our previous results with the Curtin Wellbeing Survey, we expect to annually identify about 2,285 students to be at low suicide risk, Assuming 50% of these eligible students sign up to the Managing Emotion RCT, and a 30% attrition rate, we will be seeking to recruit roughly 800 participants.

General Linear Mixed Models (GLMM), including group as a fixed factor and participant as a random effect, will be used to compare changes in outcomes measure across the three timepoints. We will conduct both intent to treat and per protocol analyses. Investigation into potential confounds will be conducted, and controlled for in the GLMM as seen appropriate. We predict significant changes in outcome measures (i.e. emotion regulation ability, emotion-related self-efficacy, resilience, mood, and self-compassion) for participants from pre- to post-intervention timepoints.

Bootstrapped mediational analyses may be conducted as seen appropriate to examine for whether any changes in emotion-based symptomatology (e.g. self-reported depression, anxiety, stress) are mediated by the factors targeted by the psychoeducation content (e.g. emotion regulation ability, self-efficacy, self-compassion).

Assessment of intervention fidelity will be explored descriptively via participant completion rates and reported treatment expectancy and rational credibility.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
23/02/2022
Actual
23/02/2022
Date of last participant enrolment
Anticipated
23/05/2023
Actual
30/10/2022
Date of last data collection
Anticipated
1/08/2024
Actual
30/10/2022
Sample size
Target
800
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 36389 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 310564 0
Charities/Societies/Foundations
Name [1] 310564 0
Curtin Alumini
Country [1] 310564 0
Australia
Primary sponsor type
Individual
Name
Prof. Penelope Hasking
Address
Curtin University
Discipline of Psychology, School of Population Health
Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 311737 0
None
Name [1] 311737 0
Address [1] 311737 0
Country [1] 311737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310172 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 310172 0
Ethics committee country [1] 310172 0
Australia
Date submitted for ethics approval [1] 310172 0
13/11/2019
Approval date [1] 310172 0
11/12/2019
Ethics approval number [1] 310172 0
HRE2019-0822

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116742 0
Prof Penelope Hasking
Address 116742 0
Curtin University
Discipline of Psychology, School of Population Health
Kent Street
Bentley WA 6102
Country 116742 0
Australia
Phone 116742 0
+61 8 9266 3437
Fax 116742 0
Email 116742 0
Penelope.Hasking@curtin.edu.au
Contact person for public queries
Name 116743 0
Penelope Hasking
Address 116743 0
Curtin University
Discipline of Psychology, School of Population Health
Kent Street
Bentley WA 6102
Country 116743 0
Australia
Phone 116743 0
+61 8 9266 3437
Fax 116743 0
Email 116743 0
Penelope.Hasking@curtin.edu.au
Contact person for scientific queries
Name 116744 0
Penelope Hasking
Address 116744 0
Curtin University
Discipline of Psychology, School of Population Health
Kent Street
Bentley WA 6102
Country 116744 0
Australia
Phone 116744 0
+61 8 9266 3437
Fax 116744 0
Email 116744 0
Penelope.Hasking@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data pertaining to the listed primary and secondary outcome measures, will be made available.
When will data be available (start and end dates)?
Data will be made available immediately following publication. End date of IPD availability has not been determined.
Available to whom?
Data availability to other researchers will be considered on a case-by-case basis at the discretion of Primary Sponsor, Prof. Penelope Hasking.
Available for what types of analyses?
Any purpose, which will be considered on a case-by-case basis at the discretion of Primary Sponsor, Prof. Penelope Hasking.
How or where can data be obtained?
Access is subject to approvals by Principal Investigator. Please email penelope.hasking@curtin.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.