Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000839909
Ethics application status
Approved
Date submitted
28/07/2020
Date registered
26/08/2020
Date last updated
11/02/2022
Date data sharing statement initially provided
26/08/2020
Date results provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of An Online Emotion Regulation Skills Program for University Students
Scientific title
Examining the Preliminary Efficacy of An Online Emotion Regulation Intervention for University Students: A Randomized Controlled Pilot Study
Secondary ID [1] 301878 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
We previously conducted an open-label study which provided initial evaluation of our emotion regulation intervention (i.e. ACTRN12620000390987). In light of positive initial findings, we are now seeking to further evaluate this intervention via an active treatment vs wait-list control pilot study.

Health condition
Health condition(s) or problem(s) studied:
Emotion regulation 318373 0
Condition category
Condition code
Mental Health 316391 316391 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 wait-list control. Questionnaire-based assessment measures will be completed immediately before and after intervention, as well as following the end of each module (see Outcomes section for detailed information). This pilot study will be conducted entirely online.
Intervention code [1] 318165 0
Behaviour
Comparator / control treatment
This study includes a wait-list control group (i.e. no treatment given). Participants who are randomly assigned to this group will be asked to complete the set of questionnaire assessment measures across two timepoints, one week apart. 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] 324544 0
Depression Anxiety Stress Scale (Lovibond & Lovibond, 1995) – A widely used 21-item self-report assessment of depression, anxiety, and stress.
Timepoint [1] 324544 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Primary outcome [2] 324545 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] 324545 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Primary outcome [3] 324546 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.
Timepoint [3] 324546 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Secondary outcome [1] 384945 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] 384945 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Secondary outcome [2] 384946 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] 384946 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Secondary outcome [3] 384947 0
Brief Resilience Scale (Smith et al, 2008) – A 6-item self-report measure of the ability to recover from stress.
Timepoint [3] 384947 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Secondary outcome [4] 384948 0
Inventory of Statements About Self-Injury (ISAS; Klonsky & Olino, 2008) – a comprehensive self-report assessment of non-suicidal self-injury
Timepoint [4] 384948 0
i. Baseline: Immediately prior to commencing Module 1
ii. Post-intervention: Immediately following completion of the final module (one week following baseline)
Note: only participants who report past or present self-injuring (item 1) are required to complete the ISAS
Secondary outcome [5] 384949 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 [5] 384949 0
i. Immediately following completion of each module

Eligibility
Key inclusion criteria
Current 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)

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 a computer-generated randomisation table (i.e. randomizer.org)
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 will be required. Assuming a 30% participant attrition rate, we will be seeking to recruit a minimum of 100 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 two 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
Completed
Date of first participant enrolment
Anticipated
7/09/2020
Actual
8/03/2021
Date of last participant enrolment
Anticipated
16/11/2020
Actual
28/05/2021
Date of last data collection
Anticipated
27/11/2020
Actual
4/06/2021
Sample size
Target
100
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306297 0
Government body
Name [1] 306297 0
WA Department of Health Merit Award
Country [1] 306297 0
Australia
Primary sponsor type
Individual
Name
Prof. Penelope Hasking
Address
Curtin University
School of Psychology
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 306790 0
None
Name [1] 306790 0
Address [1] 306790 0
Country [1] 306790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306512 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 306512 0
Ethics committee country [1] 306512 0
Australia
Date submitted for ethics approval [1] 306512 0
Approval date [1] 306512 0
11/12/2019
Ethics approval number [1] 306512 0
HRE2019-0822

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

Contacts
Principal investigator
Name 104118 0
Prof Penelope Hasking
Address 104118 0
Curtin University
School of Psychology
Kent St, Bentley WA 6102
Country 104118 0
Australia
Phone 104118 0
+61 08 9266 3437
Fax 104118 0
Email 104118 0
[email protected]
Contact person for public queries
Name 104119 0
Penelope Hasking
Address 104119 0
Curtin University
School of Psychology
Kent St, Bentley WA 6102
Country 104119 0
Australia
Phone 104119 0
+61 08 9266 3437
Fax 104119 0
Email 104119 0
[email protected]
Contact person for scientific queries
Name 104120 0
Penelope Hasking
Address 104120 0
Curtin University
School of Psychology
Kent St, Bentley WA 6102
Country 104120 0
Australia
Phone 104120 0
+61 08 9266 3437
Fax 104120 0
Email 104120 0
[email protected]

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 [email protected]


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.