Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001585213
Ethics application status
Approved
Date submitted
19/09/2018
Date registered
25/09/2018
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Date results information initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Trial Examining the Relationship Between the Frequency of Everyday Behaviours and Mental Health Before and During Treatment - the Wellbeing Course
Scientific title
An Open Trial Examining the Relationship Between the Frequency of Everyday Behaviours and Mental Health Before and During Treatment, the Wellbeing Course, for adults experiencing anxiety and depression
Secondary ID [1] 296134 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 309720 0
Depression
 309721 0
Condition category
Condition code
Mental Health 308524 308524 0 0
Anxiety
Mental Health 308525 308525 0 0
Depression

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, fortnightly during the treatment, and at post-treatment. Each set of questionnaires will take approximately 15 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). All participants will have the option of brief weekly contact (10 to 15 minutes) with a registered psychologist via telephone or a secure messaging system. The psychologist will provide support to participants as needed throughout the course.
Intervention code [1] 312464 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307499 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 307499 0
The PHQ9 will be administered at assessment, pre-treatment, fortnightly throughout treatment, and 8 weeks post-treatment. Post-treatment is the primary timepoint.
Primary outcome [2] 307500 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 307500 0
The GAD7 will be administered at assessment, pre-treatment, fortnightly throughout treatment, and 8 weeks post-treatment. Post-treatment is the primary timepoint.
Primary outcome [3] 307501 0
The Things You Do Questionnaire (TYDQ), which is a purpose built measure of everyday behaviours developed by the research team. It contains 60 items.
Timepoint [3] 307501 0
The TYDQ will be administered at assessment, pre-treatment, fortnightly throughout treatment, and 8 weeks post-treatment. Post-treatment is the primary timepoint.
Secondary outcome [1] 352081 0
Treatment credibility and expectancy questionnaire (CEQ), which is a 6 item measure designed to measure expectations of treatment outcome.
Timepoint [1] 352081 0
The CEQ will be administered at pre-treatment only.
Secondary outcome [2] 352082 0
Satisfaction With Life Scale (SWLS) is a 5 item measure of satisfaction with and quality of life.
Timepoint [2] 352082 0
The SWLS will be administered at pre-treatment and 8 weeks post-treatment.
Secondary outcome [3] 352083 0
The Brief Five Inventory 10-item (BFI-10) is a 10 item scale designed to measure the big 5 personality traits.
Timepoint [3] 352083 0
The BFI-10 will be administered at assessment, pre-treatment and 8 weeks post-treatment.

Eligibility
Key inclusion criteria
(a) Aged 18 years or older;
(b) Living in Australia; and
(c) Experiencing at least mild symptoms of general anxiety and/or depression (indicated by a total score of at least 5 on the Generalized Anxiety Disorder-7 (GAD-7) and/or the Patient Health Questionnaire-9 (PHQ-9)).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Very severe depression (i.e., indicated by a score > 25 on the PHQ-9)
(b) Acutely suicidal or recent history of attempted suicide (i.e., last 12 months)
(c) A primary problem that is not anxiety or depression (e.g., psychosis, substance abuse)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Safety/efficacy
Statistical methods / analysis
This trial is part of a program research exploring the relationship between everyday behaviours and symptoms of anxiety and depression. This particular project will explore how a range of everyday behaviours change over treatment and the relationship between change in these behaviours and symptoms of anxiety and depression. To measure the occurrence and frequency of key everyday behaviours a purpose built measure, the Things You Do Questionnaire, will be administered.

The proposed project will employ generalised estimating equations, using maximum likelihood estimation, an appropriate covariance structure to examine change in symptoms of anxiety and depression and the TYDQ over time. The sensitivity of the TYDQ and the relationship of each of its items to change will also be examined.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/09/2018
Actual
26/09/2018
Date of last participant enrolment
Anticipated
1/07/2019
Actual
28/10/2019
Date of last data collection
Anticipated
31/12/2019
Actual
6/02/2020
Sample size
Target
400
Accrual to date
Final
434
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300721 0
University
Name [1] 300721 0
Macquarie University
Country [1] 300721 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic, Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 300259 0
None
Name [1] 300259 0
Address [1] 300259 0
Country [1] 300259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301503 0
Macquarie University HREC
Ethics committee address [1] 301503 0
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Ethics committee country [1] 301503 0
Australia
Date submitted for ethics approval [1] 301503 0
15/08/2018
Approval date [1] 301503 0
03/09/2018
Ethics approval number [1] 301503 0
5201831844410

Summary
Brief summary
In a series of preliminary studies we initially developed a 12-item questionnaire known as the Frequency of Actions and Thoughts Scale (FATS; Terides et al., 2018; Terides et al., 2016) which measures coping skills and behaviours. The FATS can be administered inside and outside of therapy, and on a very frequent basis. It is highly acceptable for people experiencing distress and is psychometrically sound. Evidence for the utility of the FATS was strong, indicating that coping skills use and the practice of certain behaviours, measured using the FATS, is closely related to emotional wellbeing – both during and after therapy.

We have begun a programme of research to replicate and extend this early work. We have recently conducted a survey with more than 3,000 Australian respondents, further testing the relationship between behaviours, activities, symptoms of mood, anxiety, and levels of satisfaction with life. This survey included a larger sample of questions than used in the FATS. The results of this survey support our model that there are sets of core activities and everyday behaviours strongly associated with emotional health. We have included these key behaviours and activities in the Things You Do Questionnaire (TYDQ), which we believe can predict symptoms of anxiety and depression and, conversely, satisfaction with life.

During the present study we want to examine the relationship between everyday activities and behaviours (as measured by the TYDQ) and reductions in symptoms of anxiety and depression associated with treatment. We wish to explore whether there are certain activities and behaviours that are more related to symptoms of anxiety and depression and that change more during during treatment. Thus, the purpose of this study is not specifically to evaluate the Wellbeing Course; instead we will be using it as a means to explore the relationship between certain behaviours and emotional wellbeing, and to further evaluate and develop the TYDQ.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87218 0
A/Prof Blake Dear
Address 87218 0
Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 87218 0
Australia
Phone 87218 0
+61 2 9850 9979
Fax 87218 0
Email 87218 0
[email protected]
Contact person for public queries
Name 87219 0
A/Prof Blake Dear
Address 87219 0
Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 87219 0
Australia
Phone 87219 0
+61 2 9850 9979
Fax 87219 0
Email 87219 0
[email protected]
Contact person for scientific queries
Name 87220 0
A/Prof Blake Dear
Address 87220 0
Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 87220 0
Australia
Phone 87220 0
+61 2 9850 9979
Fax 87220 0
Email 87220 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 principal investigator can be e-mailed at: [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
SourceTitleYear of PublicationDOI
EmbaseAn open trial of the Things You Do Questionnaire: Changes in daily actions during internet-delivered treatment for depressive and anxiety symptoms.2023https://dx.doi.org/10.1016/j.jad.2023.02.117
N.B. These documents automatically identified may not have been verified by the study sponsor.