Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000124932
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
I-CBT for Stress and Well-being: Evaluating the Efficacy of a Student Focused i-CBT Intervention
Scientific title
I-CBT for Stress and Well-being: Evaluating the Efficacy of a Student Focused i-CBT Intervention
Secondary ID [1] 300362 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 315973 0
Emotional wellbeing 316143 0
Condition category
Condition code
Mental Health 314250 314250 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet cognitive behavioural therapy (i-CBT) program will comprise 8 modules (these take approximately 15 mins each) over a 6-week period that will be delivered via the This Way Up clinic website www.thiswayup.org.au. Participants will be encouraged to complete a little over one module a week, and reminded to complete modules through automated emails if they do not complete them on time. These modules are presented through comic-style illustrations that intersperse lessons in key cognitive behavioural therapy (CBT) principles alongside the narrative of a student dealing with stress. In particular these modules will cover psychoeducation on stress and well-being, skills in thought challenging, behavioural activation, goal setting, problem solving, study skills, and mindfulness. Each module ends with a lesson summary that participants can only download upon completing the module. This summary provides a brief overview of the module and includes a homework task for the student to complete before beginning the next module. For example for module 1, participants are required to complete a stress level checklist. For the relaxation module, participants are encouraged to complete relaxation activities each day, or for the managing thinking module, they are encouraged to complete a thought challenging worksheet.
Intervention code [1] 316638 0
Treatment: Other
Comparator / control treatment
Participants will be put on a waitlist for 6 weeks whilst the treatment group completes the i-CBT program first.
Control group
Active

Outcomes
Primary outcome [1] 322632 0
Change in psychological distress as measured by the Kessler-10
Timepoint [1] 322632 0
Immediately pre-intervention, immediately post-intervention (primary endpoint), and at one month follow up post-intervention.
Primary outcome [2] 322634 0
Change in well-being as measured by the World Health Organisation Five Well-being Index
Timepoint [2] 322634 0
Immediately pre-intervention, immediately post-intervention (primary endpoint), and at one month follow up post-intervention
Secondary outcome [1] 379123 0
Change in levels of depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scales-21
Timepoint [1] 379123 0
Immediately pre-intervention, immediately post-intervention (secondary endpoint), and at one month follow up post-intervention
Secondary outcome [2] 379124 0
Change in the intensity and frequency of cognitive distortions as measured by the Cognitive Distortions Questionnaire
Timepoint [2] 379124 0
Immediately pre-intervention, immediately post-intervention (secondary endpoint), and at one month follow up post-intervention

Eligibility
Key inclusion criteria
Adults aged 18 years or over
University students currently studying at UNSW Sydney
Fluent in English
Have access to a computer and the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active suicidality
Participants who are not fluent in English
Participants who do not have access to a computer

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)
Random allocation will be conducted using a 1:1 ratio by the Qualtrics survey platform randomiser function. The allocation will be concealed from the study investigators and the applicant until they meet inclusion criteria for the study and have completed the application questionnaires.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined with a power analysis, using a power of 0.8, and expected effect size of 0.4 within groups, and an effect size of 0.8 between groups. Expected effect sizes was estimated from existing literature on virtual reality interventions for public speaking anxiety.

Linear mixed models will be used to analyse the repeated measures data, with fixed factors of treatment group (iCBT/wait list), time, and the time by group interactions entered into the model. We will also conduct adjusted (with appropriate covariates) and unadjusted models to evaluate the outcomes for each of the outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2020
Actual
Date of last participant enrolment
Anticipated
19/06/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304787 0
University
Name [1] 304787 0
University of New South Wales (UNSW)
Country [1] 304787 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
Level 15 Mathews Building, UNSW, Kensington Campus. NSW, 2052, Australia
Country
Australia
Secondary sponsor category [1] 305104 0
None
Name [1] 305104 0
N/A
Address [1] 305104 0
N/a
Country [1] 305104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305201 0
UNSW Human Research Ethics Commitee
Ethics committee address [1] 305201 0
Human Research Ethics Committee (HREC) The University of New South Wales (UNSW) Sydney, NSW, Australia, 2052
Ethics committee country [1] 305201 0
Australia
Date submitted for ethics approval [1] 305201 0
Approval date [1] 305201 0
19/12/2019
Ethics approval number [1] 305201 0

Summary
Brief summary
The purpose of the study is to assess the efficacy of the i-CBT stress and well-being program for university students. We expect that the participants in the treatment group will show lower levels of psychological distress and higher levels of well-being at post-treatment and one-month follow up than participants in the waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99590 0
A/Prof Jill Newby
Address 99590 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney, NSW 2052
Country 99590 0
Australia
Phone 99590 0
+61 2 93853425
Fax 99590 0
Email 99590 0
[email protected]
Contact person for public queries
Name 99591 0
Mr Hayden Farrell
Address 99591 0
Level 13, Matthews Building, University of New South Wales UNSW, Sydney, NSW 2052
Country 99591 0
Australia
Phone 99591 0
+61 425771956
Fax 99591 0
Email 99591 0
[email protected]
Contact person for scientific queries
Name 99592 0
A/Prof Jill Newby
Address 99592 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney, NSW 2052
Country 99592 0
Australia
Phone 99592 0
+61 2 93853425
Fax 99592 0
Email 99592 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?
Data may be made available upon reasonable request. De-identified individual participant data collected during the trial that form part of the published results only may be made available on request.
When will data be available (start and end dates)?
Once the study is finished and the manuscript has been published. There will be no end date.
Available to whom?
To researchers conducting IPD meta-analyses who make reasonable requests for the data.
Available for what types of analyses?
IPD analyses (not primary analyses).
How or where can data be obtained?
By emailing the investigator ([email protected]) and requesting data to be made available.


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.