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Trial registered on ANZCTR


Registration number
ACTRN12614000596606
Ethics application status
Approved
Date submitted
2/06/2014
Date registered
4/06/2014
Date last updated
4/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural and Cognitive Change During a Self-Guided Online Cognitive Behavioural Therapy Course for Anxiety and Depression: An Open Trial
Scientific title
Behavioural and Cognitive Change During a Self-Guided Online Cognitive Behavioural Therapy Course for Anxiety and Depression: An Open Trial
Secondary ID [1] 284710 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292068 0
Anxiety 292069 0
Condition category
Condition code
Mental Health 292406 292406 0 0
Depression
Mental Health 292407 292407 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 5 lessons of an internet-delivered cognitive behaviour therapy (iCBT) treatment, the Wellbeing Course, 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] 289501 0
Treatment: Other
Intervention code [2] 289502 0
Behaviour
Comparator / control treatment
N/A - This is a single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292267 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 292267 0
Application; pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [2] 292268 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 292268 0
Application; Pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [3] 292269 0
Thoughts and Actions Frequency Scale (TAFS); This is a 24-item scale developed by the research team that measures the frequency of cognitions and behaviours related to mental health outcomes. The name of the measure is tentative and may change in future.
Timepoint [3] 292269 0
Application; Pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Secondary outcome [1] 308593 0
Satisfaction With Life Scale 5-item (SWLS), a measure of life satisfaction
Timepoint [1] 308593 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [2] 308594 0
Sheehan Disability Scale 5-item (SDS), which is a measure of general disability and impairment.
Timepoint [2] 308594 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [3] 308603 0
Locus of Control of Behaviour Scale 17 items (LCBS), a measure of patients' behaviour self-efficacy
Timepoint [3] 308603 0
Pre-treatment; week 4 of treatment; post-treatment
Secondary outcome [4] 308604 0
Therapy Evaluation Form 6-item (TEF), a measure of treatment expectations
Timepoint [4] 308604 0
Pre-treatment; week 4 of treatment; post-treatment
Secondary outcome [5] 308605 0
Behavioral Activation for Depression Scale 25-items (BADS), a measure of behavioural activation.
Timepoint [5] 308605 0
Pre-treatment; post-treatment; 3-month follow-up
Secondary outcome [6] 308606 0
Emotion Regulation Questionnaire 10 items (ERQ), a measure of emotion regulation strategies
Timepoint [6] 308606 0
Pre-treatment
Secondary outcome [7] 308607 0
Cognitive Behavior Therapy Skills Questionnaire 16-items (CBTSQ), a measure of cognitive restructuring and behavioural activation skills usage.
Timepoint [7] 308607 0
Post-treatment

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, followed by a telephone interview to confirm inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation will occur as this is a single-group trial
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

Recruitment
Recruitment status
Not yet recruiting
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] 289333 0
University
Name [1] 289333 0
eCentreClinic, the Centre for Emotional Health (CEH), Macquarie University
Address [1] 289333 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [1] 289333 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, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 288020 0
None
Name [1] 288020 0
Address [1] 288020 0
Country [1] 288020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291106 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 291106 0
Macquarie University, NSW, 2109, Australia.
Ethics committee country [1] 291106 0
Australia
Date submitted for ethics approval [1] 291106 0
19/11/2013
Approval date [1] 291106 0
28/11/2013
Ethics approval number [1] 291106 0
5201300812

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 48882 0
Dr Blake Dear
Address 48882 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 48882 0
Australia
Phone 48882 0
+61 2 9850 9979
Fax 48882 0
+61 2 9850 8062
Email 48882 0
blake.dear@mq.edu.au
Contact person for public queries
Name 48883 0
Mr Matthew Terides
Address 48883 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 48883 0
Australia
Phone 48883 0
+61 2 9850 8724
Fax 48883 0
+61 2 9850 8062
Email 48883 0
matthew.terides@mq.edu.au
Contact person for scientific queries
Name 48884 0
Dr Blake Dear
Address 48884 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 48884 0
Australia
Phone 48884 0
+61 2 9850 9979
Fax 48884 0
+61 2 9850 8062
Email 48884 0
blake.dear@mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results