Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001211550
Ethics application status
Approved
Date submitted
27/10/2015
Date registered
6/11/2015
Date last updated
11/07/2023
Date data sharing statement initially provided
11/07/2023
Date results information initially provided
11/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a tailored online program reduce mental health symptoms in adults?
Scientific title
Randomised Controlled Trial testing the effectiveness of FitMindKit, a tailored intervention, in reducing mental health symptoms
Secondary ID [1] 287390 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 296089 0
anxiety 296090 0
substance use 296091 0
suicidality 296092 0
Condition category
Condition code
Mental Health 296348 296348 0 0
Addiction
Mental Health 296349 296349 0 0
Anxiety
Mental Health 296350 296350 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The FitMindKit program consists of 18 internet-based modules adapted and abridged to encapsulate CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, exposure, motivational interviewing, mindfulness, and relaxation. These modules consist of short videos followed by activities and are based on existing evidence-based online programs. Of these modules, 10 are based on therapeutic techniques that are broadly aimed at improving general mental health, while 2 target social anxiety and panic, 2 target generalised anxiety and depression, 2 target alcohol and substance use, and 2 target suicidal thoughts. Participants are assigned 10 modules and complete 1 module per day. Each module takes approximately 10 minutes. There are 3 conditions, Tailored, Static, and Control. Participants in the Tailored condition receive a set of 10 of the 18 above modules tailored to their specific mental health symptoms, participants in the Static condition receive the 10 general mental health modules, and participants in the Control condition receive an attention=matched control program consisting of general health information not directly related to mental health.

Data measuring adherence to all three versions of the program will be automatically gathered by the online platform hosting the FitMindKit study. The adherence variables measured will include total number of visits to the site, average length of each visit, and the number of modules completed.
Intervention code [1] 292742 0
Treatment: Other
Intervention code [2] 293152 0
Behaviour
Intervention code [3] 293153 0
Lifestyle
Comparator / control treatment
There are two (2) comparison/control conditions. One, the Non-Tailored condition, is a static version of the FitMindKit program without tailoring and symptom-specific modules. The second, the Control condition, is an attention-matched control program consisting of general health information not directly related to mental health.
Control group
Active

Outcomes
Primary outcome [1] 295997 0
depression/mood symptoms as assessed by PHQ-9 and GAD-7
Timepoint [1] 295997 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Primary outcome [2] 296474 0
anxiety symptoms as assessed by PADIS and SOPHS
Timepoint [2] 296474 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Primary outcome [3] 296475 0
alcohol/substance use as assessed by AUDIT and DUDIT
Timepoint [3] 296475 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Secondary outcome [1] 318526 0
suicidal ideation as assessed by SIDAS (primary outcome)
Timepoint [1] 318526 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Secondary outcome [2] 318657 0
cost-effectiveness assessed as a composite outcome based on cost of interventions and measures of previous service use using the AHSQ, quality of life using the AQOL-4, work and social functioning using the WSAS, and days out of role using a modified version of the WHO-DAS (will be published separately from primary outcomes)
Timepoint [2] 318657 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Secondary outcome [3] 318658 0
attrition (measured by completion rate of daily assessments) (will be published separately from primary outcomes)
Timepoint [3] 318658 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Secondary outcome [4] 318659 0
adherence (measured by rate of module commencement) (will be published separately from primary outcomes)
Timepoint [4] 318659 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up
Secondary outcome [5] 318660 0
satisfaction (measured with satisfaction ratings on a 10-point Likert scale) (will be published separately from primary outcomes)
Timepoint [5] 318660 0
at post-test (the day after completion of all 10 modules) and 3 months follow-up

Eligibility
Key inclusion criteria
Elevated, but not clinical scores on the symptom scales (PHQ-9, GAD-7, PADIS, SOPHS, AUDIT, DUDIT, SIDAS) at the screening survey taken before starting the intervention. The score ranges for inclusion are as follows: PHQ-9 score of 9-20; GAD-7 score of 6-15; PADIS score of 1-6; SOPHS score of 5-12; AUDIT score of 5-15; DUDIT score of 1-6; SIDAS score of 1-20.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinical or non-elevated scores on symptom scales, not resident in Australia, currently in distress, or suicide attempt in the past year

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited to register for the study using social media advertising. Upon clicking the link, participants are immediately directed to the information sheet and a screening questionnaire. If they do not meet the eligibility criteria for the study based on their answers, they are automatically excluded and redirected to a thank-you screen and help-seeking resources.

Treatment allocation is performed by the central database and is detailed further below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants are assigned to subgroups stratified based on gender and symptom severity. This assignment is automatically performed by a script powered by the intervention host server. The script will randomly assign participants to a condition using a random number generator, with participant allocation stratified by gender and symptom severity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size of n=570 (190 in each of the 3 conditions) takes into account up to 30% attrition from the trial based on similar trials, and aims to detect an effect size of 0.4 in the primary outcomes at post-test with >90% power.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Time restraints - it took longer than anticipated to recruit participants
Date of first participant enrolment
Anticipated
9/11/2015
Actual
27/01/2016
Date of last participant enrolment
Anticipated
Actual
12/08/2016
Date of last data collection
Anticipated
Actual
8/12/2016
Sample size
Target
570
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291957 0
Charities/Societies/Foundations
Name [1] 291957 0
Australian Rotary Health
Country [1] 291957 0
Australia
Primary sponsor type
University
Name
National Institute for Mental Health Research
Address
National Institute for Mental Health Research,
63 Eggleston Road,
The Australian National University,
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 290628 0
None
Name [1] 290628 0
Address [1] 290628 0
Country [1] 290628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293450 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 293450 0
Human Ethics Officer
Chancelry Building,
10 East Road,
Acton ACT 2601
Ethics committee country [1] 293450 0
Australia
Date submitted for ethics approval [1] 293450 0
25/02/2015
Approval date [1] 293450 0
07/04/2015
Ethics approval number [1] 293450 0
2015/114

Summary
Brief summary
The aim of the project is to test the feasibility and effectiveness of the FitMindKit program to reduce symptoms of mental health problems in adults. FitMindKit is an online program that uses brief therapeutic modules (based on cognitive behavioural therapy) to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders) and suicidal thoughts. Unlike existing internet programs, FitMindKit is tailored to the individual's mental health profile, taking account of multiple mental health problems using rapid screening methods.

570 adults, 18 years and over, with elevated symptoms of depression, anxiety, and/or substance use will be recruited from the community and randomised to receive one of three programs: (i) the FitMindKit program, (ii) a static, untailored version of the FitMindKit program, or (iii) an attention-matched control program containing general health information not directly related to mental health.

We hypothesise that: (1) compared to users of the control program, users of both versions of the FitMindKit program will show a greater reduction of symptoms of depression, generalised anxiety, social anxiety, panic, alcohol and other substance use, and suicidal thoughts; (2) users of the tailored FitMindKit program will show a greater symptom reduction than users of the static FitMindKit program; (3) users of both versions of the FitMindKit program will report greater satisfaction than users of the control program; (4) users of the tailored FitMindKit program will have greater adherence to the program; and (5) the FitMindKit program will be cost-effective, through reduced need for primary care and mental health services.
Trial website
http://nimhr.anu.edu.au/research/projects
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59986 0
Dr Philip Batterham
Address 59986 0
National Institute for Mental Health Research,
63 Eggleston Road,
The Australian National University,
Acton ACT 2601
Country 59986 0
Australia
Phone 59986 0
+61 2 6125 1031
Fax 59986 0
Email 59986 0
[email protected]
Contact person for public queries
Name 59987 0
Ms Sonia McCallum
Address 59987 0
National Institute for Mental Health Research,
63 Eggleston Road,
The Australian National University,
Acton ACT 2601
Country 59987 0
Australia
Phone 59987 0
+61 2 6125 8412
Fax 59987 0
Email 59987 0
[email protected]
Contact person for scientific queries
Name 59988 0
Dr Philip Batterham
Address 59988 0
National Institute for Mental Health Research,
63 Eggleston Road,
The Australian National University,
Acton ACT 2601
Country 59988 0
Australia
Phone 59988 0
+61 2 6125 1031
Fax 59988 0
Email 59988 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?
Deidentified participant data supporting the publication results and primary outcomes
When will data be available (start and end dates)?
Data are available for an indefinite time
Start date: July 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. For further information, see https://policies.anu.edu.au/ppl/document/ANUP_007402.
Available for what types of analyses?
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. For further information, see https://policies.anu.edu.au/ppl/document/ANUP_007402.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19668Study protocol https://doi.org/10.1016%2Fj.invent.2017.08.002 
19669Data dictionary    369232-(Uploaded-26-06-2023-13-07-19)-Study-related document.xlsx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Batterham, P. J., Calear, A. L., Farrer, L., McCal... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFitMindKit: Randomised controlled trial of an automatically tailored online program for mood, anxiety, substance use and suicidality.2018https://dx.doi.org/10.1016/j.invent.2017.08.002
N.B. These documents automatically identified may not have been verified by the study sponsor.