Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000746235
Ethics application status
Approved
Date submitted
2/05/2018
Date registered
4/05/2018
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the helpfulness of an internet-delivered program for stress, anxiety, low mood and depression among University of Auckland (UOA) students.
Scientific title
Examining the helpfulness of an internet-delivered program for stress, anxiety, low mood and depression among University of Auckland (UOA) students.
Secondary ID [1] 294774 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 307682 0
Depression 307683 0
Condition category
Condition code
Mental Health 306750 306750 0 0
Anxiety
Mental Health 306751 306751 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 4 lessons of an internet-delivered cognitive behaviour therapy (iCBT) program, the UniWellbeing Course, focusing on the management of stress, anxiety, low mood and depression. All 4 Lessons will be administered via the internet and one lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous case stories about others with anxiety and depression, taking a further 15 minutes per summary. All participants will also receive automatic emails. These emails will be brief and sent each week to: (1) alert participants about new lessons available; (2) congratulate them for completing lessons; and (3) reminding them about lessons they have not completed. Weekly phone calls from a therapist from the university student counselling service will also be provided throughout the course. The duration of the phone calls is expected to be 5-10 minutes per week. The duration of the program is 5 weeks. Study questionnaires will be administered at pre-treatment, post-treatment and then 3-months post-treatment. These questionnaires will take about 5 to 10 minutes to complete at each time point. Participants lesson completion, time spent on lessons and number of logins will be recorded by the clinical software system through which participants access the course.
Intervention code [1] 301080 0
Behaviour
Intervention code [2] 301098 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305741 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 305741 0
Pre-treatment (i.e., baseline), mid-treatment (i.e., week 3), post-treatment (i.e., Week 6) and 3-month follow-up. Post-treatment (week 6) will be considered the primary end-point.
Primary outcome [2] 305742 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 305742 0
Pre-treatment (i.e., baseline), mid-treatment (i.e., week 3), post-treatment (i.e., Week 6) and 3-month follow-up. Post-treatment (week 6) will be considered the primary end-point.
Secondary outcome [1] 346330 0
Treatment Acceptability Questionnaire. The questionnaire is purpose built by the research team but has been used in numerous clinical trials (n > 50) of internet-delivered interventions involving more than 20,000 Australian adults.
Timepoint [1] 346330 0
Post-treatment (week 6).

Eligibility
Key inclusion criteria
(a) Current student of UOA.
(b) Living in New Zealand.
(b) Experiencing symptoms of stress, anxiety, low mood and depression.
(c) Wanting psychological treatment and to participate in the UniWellbeing Course.
(d) Not currently suicidal or at risk of suicide.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) A primary mental health difficulty other than stress, anxiety, low mood and depression
(b) Not wanting or interested in psychological treatment
(c) Currently suicidal or at immediate risk of suicide

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be carried out using conservative intention-to-treat principles and using generalised estimating equation (GEE) modelling. GEE modelling is a robust statistical approach for analysing clinical trial data and these analyses will employ an appropriate covariance structure and maximum likelihood estimation, which provides unbiased estimates in the case of missing data; under the assumption that data is missing at random.

With alpha set at 0.05, power set at 0.80 and a sample size of 120, the study is powered to enable the detection of small-to-large effect size (i.e., Cohen’s d > 0.30) changes in symptoms at each time point. However, 200 participants will be recruited to account for attrition and enable exploratory analyses to examine the prediction and moderation of clinical response in subgroups of participants (e.g., participants with severe versus milder symptoms).

Predictors of treatment response will be explored. Clinical outcomes will be modelled on the basis of: (1) treatment adherence and engagement; and (2) participants initial symptom levels prior to participation.

Participant recruitment will be ongoing until the revised end of the trial period (December 2022). While the minimum desired sample size has been achieved, we we have ethical approval to recruit participants for more extensive exploratory analyses. Notably, our existing research data suggests the intervention is efficacious and is currently providing free treatment that is otherwise unavailable for a treatment-seeking population.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
3/08/2018
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
2/04/2023
Actual
Sample size
Target
200
Accrual to date
616
Final
Recruitment outside Australia
Country [1] 10372 0
New Zealand
State/province [1] 10372 0
Auckland

Funding & Sponsors
Funding source category [1] 299380 0
University
Name [1] 299380 0
Macquarie University
Country [1] 299380 0
Australia
Funding source category [2] 299381 0
University
Name [2] 299381 0
University of Auckland
Country [2] 299381 0
New Zealand
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, Balaclava Road, North Ryde NSW, 2109, Australia
Country
Australia
Secondary sponsor category [1] 298659 0
University
Name [1] 298659 0
University of Auckland
Address [1] 298659 0
The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country [1] 298659 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300282 0
Macquarie University HREC
Ethics committee address [1] 300282 0
Ethics committee country [1] 300282 0
Australia
Date submitted for ethics approval [1] 300282 0
01/02/2018
Approval date [1] 300282 0
06/03/2018
Ethics approval number [1] 300282 0
5201800121

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

Contacts
Principal investigator
Name 83150 0
A/Prof Blake Dear
Address 83150 0

Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 83150 0
Australia
Phone 83150 0
+61 2 9850 9979
Fax 83150 0
Email 83150 0
[email protected]
Contact person for public queries
Name 83151 0
Blake Dear
Address 83151 0

Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 83151 0
Australia
Phone 83151 0
+61 2 9850 9979
Fax 83151 0
Email 83151 0
[email protected]
Contact person for scientific queries
Name 83152 0
Blake Dear
Address 83152 0

Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 83152 0
Australia
Phone 83152 0
+61 2 9850 9979
Fax 83152 0
Email 83152 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?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. The chief investigator can be contacted via 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.