Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001075673p
Ethics application status
Submitted, not yet approved
Date submitted
18/09/2023
Date registered
9/10/2023
Date last updated
9/10/2023
Date data sharing statement initially provided
9/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an online ultra-brief treatment for depression and anxiety for people with depression or anxiety
Scientific title
A randomised controlled trial of an online ultra-brief treatment for depression and anxiety symptoms in adults with a diagnosed depressive or anxiety disorder
Secondary ID [1] 310616 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up to ACTRN12621001617853.

Health condition
Health condition(s) or problem(s) studied:
Depression 331496 0
Anxiety 331497 0
Condition category
Condition code
Mental Health 328232 328232 0 0
Anxiety
Mental Health 328233 328233 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two arm randomised controlled trial. Participants will be randomised to treatment or a waitlist control group.

The treatment itself consists of a single online lesson which provides psychoeducation about the nature of anxiety and depression, recommendations for self-management of symptoms, and one week of optional contact with a clinician from the eCentreClinic. This intervention will also include practice exercises, illustrative case examples, and an additional resource on managing worry and problem solving. It is expected that participants will take 60 minutes to read the lesson, read the practice exercises and resource, and read the case stories. Additional skills practice is at the discretion of the participant. The materials consist of PDF and static powerpoint slides (i.e., no video or audio). Adherence will be measured by tracking the number of times a participant views or downloads each document.

The psychologist will contact participants to arrange a telephone call within a week of this lesson being released. Participants will be able to speak over the phone with the psychologist within a week of the participant viewing the lesson (i.e., this contact is not limited to the week that the treatment becomes available to accommodate participant availability). There is no time limit to this telephone consult or private messages, although it is expected that phone consults will be 20-30 minutes long. The purpose of this contact is to reinforce the lesson content, support the participant to use the skills, and answer any questions they may have. Additional contact outside this week will be made if participants indicate that they are at risk of suicide/ self-harm or are experiencing technical difficulties.
Intervention code [1] 327020 0
Treatment: Other
Comparator / control treatment
The waitlist control will receive access to treatment after a 17-week waiting period. Participants' depression and anxiety symptoms will be monitored by psychologists during this time, and participants are able to contact the eCentreClinic at any time if required.
Control group
Active

Outcomes
Primary outcome [1] 336099 0
Depression
Timepoint [1] 336099 0
Baseline, every two weeks for four months (i.e., 16 weeks), and 17-weeks post-baseline. The primary timepoint is Week 17 post-baseline.
Primary outcome [2] 336169 0
Anxiety
Timepoint [2] 336169 0
Baseline, every two weeks for four months (i.e., 16 weeks), and 17-weeks post-baseline. The primary timepoint is Week 17 post-baseline.
Secondary outcome [1] 426833 0
Insight into psychological difficulties
Timepoint [1] 426833 0
Baseline, every two weeks for four months (i.e., 16 weeks), and 17-weeks post-baseline.
Secondary outcome [2] 426834 0
Therapeutic realisations
Timepoint [2] 426834 0
Baseline, every two weeks for four months (i.e., 16 weeks), and 17-weeks post-baseline. The primary timepoint is Week 17 post-baseline.

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older
(c) Meets diagnostic criteria for a depressive or anxiety disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe
(b) Living outside of Australia
(c) Unable to read and understand English.

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)
Allocation concealment is ensured by having a blacked out column in an Excel sheet which is only visible after the assessment has been conducted. In other words, the psychologist who completes the phone assessment will not know the group allocation until after the assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to two groups. Randomisation will occur using a computer-generated randomisation sequence (using www.random.org) by an independent researcher not involved in the recruitment of participants. This sequence will be generated prior to enrolment of the first participant, which ensures that the research team are unable to affect group allocation.
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
Generalized estimating equations will be used to examine change in depressive and anxiety symptoms over time according to group allocation. Multiple imputation will be used to handle missing data, consistent with intent-to-treat.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314833 0
University
Name [1] 314833 0
Macquarie University
Country [1] 314833 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
16 University Avenue, Macquarie Park, NSW, 2109
Country
Australia
Secondary sponsor category [1] 316822 0
None
Name [1] 316822 0
None
Address [1] 316822 0
None
Country [1] 316822 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313835 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 313835 0
Balaclava Rd, Macquarie Park NSW 2109
Ethics committee country [1] 313835 0
Australia
Date submitted for ethics approval [1] 313835 0
11/09/2023
Approval date [1] 313835 0
Ethics approval number [1] 313835 0

Summary
Brief summary
Our previous research found that an ultra-brief online treatment was effective for managing depression and anxiety symptoms. This research trial is testing how quickly people with a diagnosed depressive or anxiety disorder benefit from an ultra-brief treatment. People will be randomly allocated to receive access immediately or after a 4-month waiting period. Questionnaires will be administered every 2 weeks for 4 months. The primary endpoint is Week 17 and we expect that the treatment will result in larger reductions in depression and anxiety compared to the control.
Trial website
https://www.ecentreclinic.org/single-session-course
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129498 0
Dr Madelyne Bisby
Address 129498 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129498 0
Australia
Phone 129498 0
+61 298508724
Fax 129498 0
Email 129498 0
madelyne.bisby@mq.edu.au
Contact person for public queries
Name 129499 0
Dr Madelyne Bisby
Address 129499 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129499 0
Australia
Phone 129499 0
+61 298508724
Fax 129499 0
Email 129499 0
madelyne.bisby@mq.edu.au
Contact person for scientific queries
Name 129500 0
Dr Madelyne Bisby
Address 129500 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129500 0
Australia
Phone 129500 0
+61 298508724
Fax 129500 0
Email 129500 0
madelyne.bisby@mq.edu.au

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. Data can be obtained by e-mailing the principal investigator (madelyne.bisby@mq.edu.au)


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.