Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001099617
Ethics application status
Approved
Date submitted
10/10/2014
Date registered
16/10/2014
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Date results provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of internet Cognitive Behaviour Therapy in tertiary students experiencing depression and anxiety as a part of a stepped care student counselling service.
Scientific title
An investigation of the effectiveness of internet Cognitive Behaviour Therapy in tertiary students experiencing depression and anxiety as a part of a stepped care student counselling service.
Secondary ID [1] 285480 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety
 293263 0
Depression 293301 0
Condition category
Condition code
Mental Health 293530 293530 0 0
Anxiety
Mental Health 293531 293531 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 stories about others with anxiety and depression, taking a further 20 minutes per summary. All participants will also receive automatic email and weekly reminder phone calls by a psychologist. The duration of the reminder emails and 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 minutes to complete.
Intervention code [1] 290419 0
Behaviour
Intervention code [2] 290444 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293351 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 293351 0
Pre-treatment (i.e., baseline), mid-treatment (i.e., week 3), post-treatment (i.e., Week 6) and 3-month follow-up.
Primary outcome [2] 293352 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 293352 0
Pre-treatment (i.e., baseline), mid-treatment (i.e., week 3), post-treatment (i.e., Week 6) and 3-month follow-up.
Secondary outcome [1] 310832 0
Treatment Acceptability Questionnaire
Timepoint [1] 310832 0
Post-treatment

Eligibility
Key inclusion criteria
- Aged 18+
- Who are either experience anxiety and/or depression or want to participate in a course to learn to manage these conditions.
- Enrolled student at Macquarie University, Sydney, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current intention or plans concerning suicide
- Recent history of suicide attempts (i.e., within last 12 months)

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)
Participants will learn about the trial via the Macquarie University Campus Wellbeing Service, which provides a broad range of psychological and physical health support services to students at the University. All interested participants will complete the DSM V Level 1 Self Rated Cross-Cutting Symptom Measure. Participants who have anxiety or depression scores of < 4 will and who score < 3 on the safety question will be offered the opportunity to participate in the program immediately. Participants with anxiety or depression scores > 3 or safety scores > 3 will be be referred for an assessment with a clinician before any offer of participation is made. Suitable participants will be provided with login details and a start date for the program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/a
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 mixed-linear models analyses to handle missing data. Mixed-models are 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.

Sample size: With an alpha at 0.05 and power set at 0.80, 27 participants are needed to detect an effect size improvement in symptoms of .50. However, to hedge against attrition and enable the robust estimation and exploration of treatment effects many more participants will be recruited - i.e., based on previous experience, we have capacity to recruit and treat as many as 150 students in the next 9 months, which would provide us with a more robust exploration of the treatment effects compared to smaller samples of, for example, 27 participants. The effect size of 0.50 is also conservative estimate with larger effect sizes having been observed in previous trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2014
Actual
24/10/2014
Date of last participant enrolment
Anticipated
1/12/2015
Actual
30/09/2018
Date of last data collection
Anticipated
Actual
31/03/2019
Sample size
Target
150
Accrual to date
Final
1080
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8816 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 290082 0
University
Name [1] 290082 0
Macquarie University
Country [1] 290082 0
Australia
Primary sponsor type
University
Name
eCentreClinic, Macquarie University
Address
Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 288780 0
University
Name [1] 288780 0
Campus Wellbeing, Macquarie University
Address [1] 288780 0
Macquarie University, NSW, 2109, Australia.
Country [1] 288780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291788 0
Macquarie University, Human Research Ethics Committee
Ethics committee address [1] 291788 0
Ethics committee country [1] 291788 0
Australia
Date submitted for ethics approval [1] 291788 0
Approval date [1] 291788 0
22/07/2014
Ethics approval number [1] 291788 0
5201400474

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

Contacts
Principal investigator
Name 52038 0
Prof Michael Jones
Address 52038 0
Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 52038 0
Australia
Phone 52038 0
+61 2 9850 8601
Fax 52038 0
Email 52038 0
[email protected]
Contact person for public queries
Name 52039 0
Blake Dear
Address 52039 0
Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 52039 0
Australia
Phone 52039 0
+61 2 9850 9979
Fax 52039 0
Email 52039 0
[email protected]
Contact person for scientific queries
Name 52040 0
Blake Dear
Address 52040 0
Department of Psychology Macquarie University Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 52040 0
Australia
Phone 52040 0
+61 2 9850 9979
Fax 52040 0
Email 52040 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 e-mail: [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.