ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

Depression symptoms (PhQ-9)

Timepoint [1]

Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)

Secondary outcome [1]

Anxiety symptoms (GAD-7)

Timepoint [1]

Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)

Secondary outcome [2]

Panic symptoms (Panic Disorder Screener)

Timepoint [2]

Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)

Secondary outcome [3]

Social anxiety (Social Anxiety Disorder screener)

Timepoint [3]

Pre-intervention, post-intervention (4 weeks after the pre-intervention assessment)

Secondary outcome [4]

Suicidal ideation (SIDAS)

Timepoint [4]

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?

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Alison Calear

Address [1]

Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian National University Human Research Ethics Committee

Ethics committee address [1]

Level 1, Geography Building 48A
Linnaeus Way, The Australian National University
Canberra, ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/12/2017

Approval date [1]

26/03/2018

Ethics approval number [1]

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

A/Prof Philip Batterham

Address

Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601

Country

Australia

Phone

+61 2 6125 1031

Fax

philip.batterham@anu.edu.au

Contact person for public queries

Name

Ella Kurz

Address

Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601

Country

Australia

Phone

+61 2 6125 8572

Fax

ella.kurz@anu.edu.au

Contact person for scientific queries

Name

Ella Kurz

Address

Building 63 Eggleston Road
The Australian National University
Canberra ACT 2601

Country

Australia

Phone

+61 2 6125 8572

Fax

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7042	Study protocol	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.	https://www.sciencedirect.com/science/article/pii/S2451865418301972
19665	Data dictionary					376113-(Uploaded-26-06-2023-12-00-15)-Study-related document.xlsx

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	Efficacy of a transdiagnostic, video-based online program for reducing depression, anxiety, and suicidal ideation in adults: Protocol for a randomised controlled trial.	2019	https://dx.doi.org/10.1016/j.conctc.2019.100341
Embase	Efficacy of a Transdiagnostic Self-Help Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation in Adults: Randomized Controlled Trial.	2021	https://dx.doi.org/10.2196/22698
Embase	The Effect of Dissemination Pathways on Uptake and Relative Costs for a Transdiagnostic, Self-guided Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation: Comparative Implementation Study.	2022	https://dx.doi.org/10.2196/34769

N.B. These documents automatically identified may not have been verified by the study sponsor.

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