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Trial registered on ANZCTR


Registration number
ACTRN12615000112561
Ethics application status
Approved
Date submitted
27/01/2015
Date registered
6/02/2015
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural and Cognitive Changes During Self-Guided Internet-Delivered Cognitive-Behavioural Therapy for Anxiety and Depression: A Randomised Controlled Trial
Scientific title
Behavioural and Cognitive Changes During Self-Guided Internet-Delivered Cognitive-Behavioural Therapy for Anxiety and Depression: A Randomised Controlled Trial
Secondary ID [1] 286054 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294034 0
Anxiety 294035 0
Condition category
Condition code
Mental Health 294336 294336 0 0
Depression
Mental Health 294337 294337 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to either an active internet-delivered cognitive-behavioural therapy (iCBT) treatment group, or to a wait-list control group, who will receive the same iCBT treatment when the active treatment group has finished. The iCBT treatment course, The Wellbeing Course, is a 5-lesson program focusing on the management of anxiety and depression. All 5 Lessons will be administered online (via the internet); each 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 other people with depression and anxiety, taking a further 20 minutes per summary. All participants will also receive weekly reminder emails informing them when lessons become available. The duration of the reminder emails will take an additional 2 minutes to access and read. The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-treatment, during the treatment, post-treatment, and 3 months post-treatment. These questionnaires at application, pre-treatment, post-treatment and 3-months follow up will take about 10-15 minutes to complete. The questionnaires administered during the treatment will take approximately 3 minutes to complete. The software presenting the iCBT treatment course will also record information to inform adherence to the intervention (e.g. lessons completed, download history of other treatment materials in the course, number of logins, and duration of logins)
Intervention code [1] 291041 0
Behaviour
Intervention code [2] 291117 0
Treatment: Other
Comparator / control treatment
Wait-list control group

The Wait-list control group will begin the Wellbeing Course after the 8-week intervention period for the active treatment group.
Control group
Active

Outcomes
Primary outcome [1] 294136 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 294136 0
Application; pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [2] 294137 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 294137 0
Application; Pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [3] 294138 0
Frequency of Actions and Thoughts Scale (FATS)
This is a 24-item scale developed by the research team that measures the frequency of cognitions and behaviours related to mental health outcomes.
Timepoint [3] 294138 0
Application; Pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Secondary outcome [1] 312588 0
Mini Social Phobia Inventory (MINI-SPIN):

This is a measure of social anxiety
Timepoint [1] 312588 0
pre-treatment, post-treatment, 3-month follow-up.
Secondary outcome [2] 312589 0
Satisfaction With Life Scale 5-item (SWLS), a measure of life satisfaction
Timepoint [2] 312589 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [3] 312590 0
Sheehan Disability Scale 5-item (SDS), which is a measure of general disability and impairment.
Timepoint [3] 312590 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [4] 312591 0
The Panic Disorder Severity Rating Scale-Self Report (PDSS-SR). A measure of panic disorder symptoms
Timepoint [4] 312591 0
pre-treatment, post-treatment, and 3-month follow-up
Secondary outcome [5] 312592 0
MINI diagnostic Interview.

A brief, structured interview for diagnosing mental health disorders.

Timepoint [5] 312592 0
pre-treatment, and 3-month follow-up.

Eligibility
Key inclusion criteria
- Self-reported difficulties with anxiety or depression.
- Internet access + Printer access
- Australian resident
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving concurrent CBT
- Severe symptoms of depression
- Severe depression, suicidal intent or plan (PHQ-9 total score > 23; or >2 to PHQ-9 question assessing frequency of self-harm or suicide ideation)

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)
Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
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
Analyses of clinical outcomes will be done 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.

Mixed multilevel mediation analysis will also be conducted to investigate the FATS measure as a mediator of symptom change.


With alpha set at .05, and power at .80, a total sample size of 200 participants will be sufficient to observe medium and larger effect sizes (i.e. Cohen's D >0.5) on outcome measures using mixed linear modelling, while hedging against attrition.

For multilevel mediation analysis, less is known about required sample size, as it is a relatively new statistical technique, and there is not much empirical data available on our constructs of interest. However, Li and Beretvas (2013) suggest that these models can successfully converge with a sample size of at least 80, and Preacher, Zhang, and Zyphur (2011), using simulated data, suggest that sample sizes between 100 and 300 have sufficient power, provided that the population intraclass correlation is high (> .4), and the effect size is at least moderate (.3). Based on our previous single-group open trial, the pre-post within group effect size on our constructs of interest were large (>.8), and based on sample data from our previous trials, the intraclass correlation is also high (>.4), suggesting that a sample size of 200 will be sufficient to detect our effects of interest, and hedge against attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290640 0
University
Name [1] 290640 0
eCentreClinic, the Centre for Emotional Health (CEH), Macquarie University
Address [1] 290640 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, North Ryde, NSW, 2109, Australia.
Country [1] 290640 0
Australia
Primary sponsor type
University
Name
eCentreClinic, the Centre for Emotional Health (CEH), Macquarie University
Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, North Ryde, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 289334 0
None
Name [1] 289334 0
Address [1] 289334 0
Country [1] 289334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292273 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 292273 0
Macquarie University, NSW, 2109, Australia.
Ethics committee country [1] 292273 0
Australia
Date submitted for ethics approval [1] 292273 0
12/11/2014
Approval date [1] 292273 0
22/01/2015
Ethics approval number [1] 292273 0
5201401119

Summary
Brief summary
This project is part of a research program examining the role that certain cognitions and behaviours play in mediating symptom reduction of internet-delivered cognitive behavioural therapy for depression and anxiety.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54414 0
Dr Blake Dear
Address 54414 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 54414 0
Australia
Phone 54414 0
+61 2 9850 9979
Fax 54414 0
+61 2 9850 8062
Email 54414 0
blake.dear@mq.edu.au
Contact person for public queries
Name 54415 0
Mr Matthew Terides
Address 54415 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 54415 0
Australia
Phone 54415 0
+61 2 9850 8724
Fax 54415 0
+61 2 9850 8062
Email 54415 0
matthew.terides@mq.edu.au
Contact person for scientific queries
Name 54416 0
Dr Blake Dear
Address 54416 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 54416 0
Australia
Phone 54416 0
+61 2 9850 9979
Fax 54416 0
+61 2 9850 8062
Email 54416 0
blake.dear@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary