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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.

Timepoint [1]

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]

Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.

Timepoint [2]

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]

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]

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]

Treatment credibility and expectancy questionnaire (CEQ), which is a 6 item measure designed to measure expectations of treatment outcome.

Timepoint [1]

The CEQ will be administered at pre-treatment only.

Secondary outcome [2]

Satisfaction With Life Scale (SWLS) is a 5 item measure of satisfaction with and quality of life.

Timepoint [2]

The SWLS will be administered at pre-treatment and 8 weeks post-treatment.

Secondary outcome [3]

The Brief Five Inventory 10-item (BFI-10) is a 10 item scale designed to measure the big 5 personality traits.

Timepoint [3]

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?

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]

University

Name [1]

Macquarie University

Address [1]

eCentreClinic, Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University HREC

Ethics committee address [1]

Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2018

Approval date [1]

03/09/2018

Ethics approval number [1]

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

A/Prof Blake Dear

Address

Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.

Country

Australia

Phone

+61 2 9850 9979

Fax

[email protected]

Contact person for public queries

Name

Blake Dear

Address

Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.

Country

Australia

Phone

+61 2 9850 9979

Fax

[email protected]

Contact person for scientific queries

Name

Blake Dear

Address

Director, eCentreClinic
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.

Country

Australia

Phone

+61 2 9850 9979

Fax

[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

Source	Title	Year of Publication	DOI
Embase	An open trial of the Things You Do Questionnaire: Changes in daily actions during internet-delivered treatment for depressive and anxiety symptoms.	2023	https://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.

Trial Review

Documents added manually

Documents added automatically