Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001688279
Ethics application status
Approved
Date submitted
9/10/2018
Date registered
12/10/2018
Date last updated
11/07/2023
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a video-based online intervention in reducing depression and anxiety in adults
Scientific title
Randomised controlled trial of a transdiagnostic online video-based intervention for reducing depression and anxiety in adults
Secondary ID [1] 296231 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 309985 0
Anxiety 309986 0
Condition category
Condition code
Mental Health 308754 308754 0 0
Depression
Mental Health 308755 308755 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (FitMindKit) consists of 12 modules containing CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, and mindfulness. Each module consists of a brief video (a transcript will be available through a link) followed by an exercise to practice the therapeutic technique that is described. FitMindKit is designed to target symptoms of depression and anxiety. Participants will have access to the 12 modules over a period of 4 weeks and the modules are entirely self-guided and available online. Each module takes 10 minutes to complete. Adherence to the program will be assessed by the number of modules completed.
Intervention code [1] 312629 0
Treatment: Other
Comparator / control treatment
The control program (HealthWatch) consists of 12 10-minute modules containing health information not directly related to mental health. This information will be delivered online and is text-based. Examples of health topics covered in the modules include bone health, allergens, and sun exposure. Participants will have access to the modules for 4 weeks, and adherence will be assessed by the number of modules completed.
Control group
Active

Outcomes
Primary outcome [1] 307735 0
Depression symptoms (PhQ-9)
Timepoint [1] 307735 0
Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)
Secondary outcome [1] 352717 0
Anxiety symptoms (GAD-7)
Timepoint [1] 352717 0
Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)
Secondary outcome [2] 352718 0
Panic symptoms (Panic Disorder Screener)
Timepoint [2] 352718 0
Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)
Secondary outcome [3] 352719 0
Social anxiety (Social Anxiety Disorder screener)
Timepoint [3] 352719 0
Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)
Secondary outcome [4] 352720 0
Suicidal ideation (SIDAS)
Timepoint [4] 352720 0
Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)

Eligibility
Key inclusion criteria
Eligible participants are those aged 18 years and over, and who indicate a moderate level of psychological distress (score of 8-17 on the DQ-5).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Participants will be randomly allocated to a condition by automated computer program, As allocation will not be completed by a person, it is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a randomisation table created by computer software (i.e. computerised sequence generation). Participants will be randomised in blocks of 6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2018
Actual
31/10/2018
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
31/10/2019
Sample size
Target
750
Accrual to date
Final
1986
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 300831 0
Government body
Name [1] 300831 0
National Health and Medical Research Council
Country [1] 300831 0
Australia
Primary sponsor type
Individual
Name
Philip Batterham
Address
Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 300375 0
Individual
Name [1] 300375 0
Alison Calear
Address [1] 300375 0
Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601
Country [1] 300375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301600 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 301600 0
Level 1, Geography Building 48A
Linnaeus Way, The Australian National University
Canberra, ACT 2601
Ethics committee country [1] 301600 0
Australia
Date submitted for ethics approval [1] 301600 0
20/12/2017
Approval date [1] 301600 0
26/03/2018
Ethics approval number [1] 301600 0
2017/911

Summary
Brief summary
This trial will test the effectiveness of a brief, video-based online program for reducing depression and anxiety in Australian adults (FitMindKit). Those with elevated psychological distress will be invited to participate and randomised to use either FitMindKit or a comparable general health online program (HealthWatch) for a period of 4 weeks. FitMindKit is an online program that uses brief therapeutic modules to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders). The intervention consists of 12 modules adapted and abridged to encapsulate CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, and mindfulness. Participants will complete brief pre- and post-program questionnaires, and will receive weekly e-mail reminders to use FitMindKit or HealthWatch. Outcome measures include depression and anxiety symptoms. It is hypothesised that those who receive the FitMindKit program will show significant reductions in depression and anxiety symptoms relative to those in the control condition post-intervention. It is also hypothesised that greater adherence to the intervention (number of modules completed) will be observed in the intervention group relative to the control group, and that greater adherence will be associated with greater reductions in depression and anxiety symptoms post-intervention among those who receive the FitMindKit program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87510 0
A/Prof Philip Batterham
Address 87510 0
Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601
Country 87510 0
Australia
Phone 87510 0
+61 2 6125 1031
Fax 87510 0
Email 87510 0
philip.batterham@anu.edu.au
Contact person for public queries
Name 87511 0
Ms Ella Kurz
Address 87511 0
Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601
Country 87511 0
Australia
Phone 87511 0
+61 2 6125 8572
Fax 87511 0
Email 87511 0
ella.kurz@anu.edu.au
Contact person for scientific queries
Name 87512 0
Ms Ella Kurz
Address 87512 0
Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601
Country 87512 0
Australia
Phone 87512 0
+61 2 6125 8572
Fax 87512 0
Email 87512 0
ella.kurz@anu.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?
Deidentified participant data supporting the publication results and relating to primary outcomes
When will data be available (start and end dates)?
Data are available for an indefinite time
Start date: May 2023 (approx)
End date: Unknown
Available to whom?
Data are potentially available to researchers from not-for-profit organisations based in any location. All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Relevant institutional policy is available at https://policies.anu.edu.au/ppl/document/ANUP_007402.
Available for what types of analyses?
Any type of analysis including IPD meta-analysis or systematic review, assessed on a case-by-case basis.
How or where can data be obtained?
As of 1st July 2023, access can be requested via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.
What supporting documents are/will be available?
Study protocol
Data dictionary
How or where can supporting documents be obtained?
Type [1] 7042 0
Study protocol
Citation [1] 7042 0
Batterham, Calear, Gulliver, & Farrer. (2019). Efficacy of a transdiagnostic, video-based online program for reducing depression, anxiety, and suicidal ideation in adults: Protocol for a randomised controlled trial. Contemporary clinical trials communications, 14, 100341.

Link [1] 7042 0
https://www.sciencedirect.com/science/article/pii/S2451865418301972
Email [1] 7042 0
Other [1] 7042 0
Attachment [1] 7042 0
Type [2] 19665 0
Data dictionary
Citation [2] 19665 0
Link [2] 19665 0
Email [2] 19665 0
Other [2] 19665 0
Attachment [2] 19665 0
/Steps11and12/376113-(Uploaded-26-06-2023-12-00-15)-Study-related document.xlsx
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 12400 0
Batterham, P. J., Calear, A. L., Farrer, L., Gulliver, A., & Kurz, E. (2021). Efficacy of a Transdiagnostic Self-Help Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation in Adults: Randomized Controlled Trial. Journal of Medical Internet Research, 23(1), e22698.
Attachments [1] 12400 0
/Steps11and12/376113-(Uploaded-26-01-2021-11-37-11)-Journal results publication.pdf
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary