Trial Review

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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
4/02/2021
Date data sharing statement initially provided
4/02/2021
Date results provided
4/02/2021
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
5/06/2014
Actual
5/06/2014
Date of last participant enrolment
Anticipated
Actual
4/07/2014
Date of last data collection
Anticipated
Actual
4/01/2015
Sample size
Target
150
Accrual to date
Final
125
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
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
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
Trial website
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
[email protected]
Contact person for public queries
Name 48883 0
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
[email protected]
Contact person for scientific queries
Name 48884 0
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
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers working with the approval and under the governance of a Human Research Ethics Committee.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.

What types of analyses could be done with individual participant data?
• Any analyses required to verify the outcomes reported in published reports

When can requests for individual participant data be made (start and end dates)?
From:
Data will be made after any original reports have been published. There will be no end date to the availability.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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. Data can be obtained by e-mailing the chief investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.