Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001617853
Ethics application status
Approved
Date submitted
21/10/2021
Date registered
26/11/2021
Date last updated
16/11/2023
Date data sharing statement initially provided
26/11/2021
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A single session intervention for anxiety and depression: a randomised controlled trial
Scientific title
Effect of a single vs. multi-session intervention on anxiety and depression symptoms in adults: a randomised controlled trial
Secondary ID [1] 305617 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 324047 0
Depression 324048 0
Condition category
Condition code
Mental Health 321561 321561 0 0
Anxiety
Mental Health 321562 321562 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three-arm randomized controlled trial will be employed, where participants are randomized to one of three groups:
1. Single session intervention
2. Multi session intervention
3. Waitlist Control

The Single Session Intervention comprises 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. The lesson is based on Lesson 1 of the Wellbeing Course with four additional slides which outline possible strategies for participants to practice. This intervention will also include practice exercises, an additional resource on problem solving, and case stories from example participants to illustrate the skills. 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 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. 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.
The second treatment is the Wellbeing Course. This Course is based on cognitive behaviour therapy and includes five lessons released over an 8-week period, in addition to optional contact with a clinician from the eCentreClinic. The five lessons focus on psychoeducation (Lesson 1), cognitive challenging (Lesson 2), arousal management (Lesson 3), activity scheduling and exposure (Lesson 4), and relapse management (Lesson 5). This Course also includes additional resources (e.g., assertive communication), case stories from past participants, and automatic emails on a weekly basis. Participants are expected to spend 3-4 hours a week working through the Wellbeing Course materials - this includes reading the lesson, thinking about the content, and practicing the skills. The contact with a psychologist will be via telephone or private messaging. From past clinical experience, this is usually one 20-30 min phone call or 3-4 private messages per week.
Lessons in the single session and multi-session intervention consist of text and static images (i.e., no video or audio). The Wellbeing Course has been used in several past clinical trials and is provided at the MindSpot Clinic (https://mindspot.org.au/wellbeing-course).
Intervention code [1] 322021 0
Treatment: Other
Comparator / control treatment
The waitlist control group will receive access to the Wellbeing Course after an 8-week waiting period.
Control group
Active

Outcomes
Primary outcome [1] 329324 0
Anxiety symptoms, as assessed by the GAD-7
Timepoint [1] 329324 0
All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks after baseline. The primary endpoint will be 8-weeks after baseline (i.e., Week 9).
Primary outcome [2] 329325 0
Depression symptoms, as assessed by the PHQ-9
Timepoint [2] 329325 0
All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks after baseline. The primary endpoint will be 8-weeks after baseline (i.e., Week 9).
Secondary outcome [1] 402140 0
Disability, as assessed by the Sheehan Disability Scale
Timepoint [1] 402140 0
All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks after baseline. The primary endpoint will be 8-weeks after baseline (i.e., Week 9).

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older
(c) Report primary difficulties with anxiety and/or depression
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 1:1:1 to the three 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2022
Actual
8/02/2022
Date of last participant enrolment
Anticipated
Actual
18/08/2022
Date of last data collection
Anticipated
Actual
22/12/2022
Sample size
Target
240
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309980 0
University
Name [1] 309980 0
Macquarie University
Country [1] 309980 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
73 Talavera Road, Macquarie Park, NSW, 2109
Country
Australia
Secondary sponsor category [1] 311028 0
None
Name [1] 311028 0
None
Address [1] 311028 0
None
Country [1] 311028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309690 0
MQ Human Research Ethics Committee
Ethics committee address [1] 309690 0
Balaclava Rd, Macquarie Park NSW 2109
Ethics committee country [1] 309690 0
Australia
Date submitted for ethics approval [1] 309690 0
11/10/2021
Approval date [1] 309690 0
26/11/2021
Ethics approval number [1] 309690 0

Summary
Brief summary
The primary aim of this project is to determine whether a single session intervention is no less effective (i.e., non-inferior) in reducing anxiety and depressive symptoms compared to a multi-session intervention, the Wellbeing Course. The secondary aim of this project is to determine whether the single session intervention is more effective than a waitlist control group. Participants in the SSI will receive access to a single online lesson and will be invited to contact the clinician within the 1-week following the release of the lesson. Participants in the MSI will receive access to the 8-week intervention and contact with the clinician. Participants in the Waitlist Control Group will receive access to the MSI following the 8-week waitlist period. All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks later. The primary endpoint will be 8-weeks after pre-treatment (i.e., Week 9).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115050 0
Dr Madelyne Bisby
Address 115050 0
Macquarie University, 73 Talavera Road, Macquarie Park, NSW, 2109
Country 115050 0
Australia
Phone 115050 0
+61 2 98508724
Fax 115050 0
Email 115050 0
[email protected]
Contact person for public queries
Name 115051 0
Dr Madelyne Bisby
Address 115051 0
Macquarie University, 73 Talavera Road, Macquarie Park, NSW, 2109
Country 115051 0
Australia
Phone 115051 0
+61 2 98508724
Fax 115051 0
Email 115051 0
[email protected]
Contact person for scientific queries
Name 115052 0
Dr Madelyne Bisby
Address 115052 0
Macquarie University, 73 Talavera Road, Macquarie Park, NSW, 2109
Country 115052 0
Australia
Phone 115052 0
+61 2 98508724
Fax 115052 0
Email 115052 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. Data can be obtained by e-mailing the principal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Bisby, M., Balakumar, T., Scott, A., Titov, N., & ... [More Details]

Documents added automatically
No additional documents have been identified.