Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001565235
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
19/09/2018
Date last updated
11/07/2023
Date data sharing statement initially provided
22/08/2019
Date results provided
11/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing engagement with online programs to improve mental health in the community: The Engagement Project
Scientific title
Randomised controlled trial examining the effect of a brief intervention on the uptake and adherence of a self-guided mental health program for depression and anxiety.
Secondary ID [1] 295864 0
None
Universal Trial Number (UTN)
U1111-1219-7728
Trial acronym
Enhancing Engagement with Psychosocial Interventions (EEPI)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 309353 0
Anxiety 309354 0
Condition category
Condition code
Mental Health 308215 308215 0 0
Depression
Mental Health 308216 308216 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - AFI + myCompass 2
Arm 2 - myCompass 2 alone

AFI:
The Acceptance-Facilitation Intervention (AFI) will consist of brief (approximately 5 minutes), tailored material presented online to the participant after they are randomised to a condition but before they start the myCompass 2 intervention. The material will be designed to challenge many of the personal barriers to engagement with psychosocial interventions, informed by theory emphasising the importance of social norms in the acceptability of online psychosocial programs.

myCompass 2:
myCompass 2 is an updated version of the previously evaluated myCompass online program. It is a fully automated, interactive self-help program that is delivered via the Internet. The program provides people experiencing mild-to-moderate symptoms of stress, anxiety and/or depression, with 24/7 access to a private, personalised and evidence-based treatment program.

myCompass 2 contains 14 modules derived from cognitive behaviour therapy (CBT), problem solving therapy, interpersonal psychotherapy and positive psychology. Seven modules provide core transdiagnostic CBT, while the remaining seven are tailored to specific mental health concerns. Other features include real-time self-monitoring of thoughts, feelings and behaviours (via mobile phone or computer); SMS or email self-monitoring reminders; graphical feedback about self-monitoring information; and helpful facts, mental health-care tips or motivational statements (via SMS or email). myCompass 2 is tailored to user needs, with screening scales used to profile the participant and provide them with recommendations as to which modules would be most suitable for them. myCompass 2 is delivered over 7 weeks to enable sufficient time to complete all of the available modules. It is expected that users will complete two modules per week for 7 weeks. Each module takes 30-45 minutes to complete.

Intervention delivery and assessments will be automated. Online usage data is automatically collected by the myCompass program for each user.
Intervention code [1] 312294 0
Treatment: Other
Comparator / control treatment
The attention control condition will consist of 14 brief modules of public domain health and lifestyle information, matched for time taken to complete the myCompass 2 program. After participants have completed their follow-up surveys they will be invited to use the myCompass 2 program.
Control group
Active

Outcomes
Primary outcome [1] 307286 0
Uptake as assessed by - number of individuals who access at least one therapeutic module of the program.
Timepoint [1] 307286 0
7 weeks post-randomisation
Primary outcome [2] 307287 0
Adherence as assessed by number of modules completed of myCompass 2
Timepoint [2] 307287 0
7 weeks post-randomisation
Secondary outcome [1] 351384 0
Depression efficacy as assessed by reductions in PHQ-9 scores.
Timepoint [1] 351384 0
7 weeks post-randomisation, 6 months after post-intervention
Secondary outcome [2] 351385 0
Anxiety efficacy as assessed by reductions in GAD-7 scores.
Timepoint [2] 351385 0
7 weeks post-randomisation, 6 months after post-intervention
Secondary outcome [3] 351386 0
Acceptability UTAUT (Unified Theory of Acceptance and Use of Technology measure) and (PCTQ-P) Perceptions of Computerized Therapy Questionnaire-Patient Version
Timepoint [3] 351386 0
7 weeks post-randomisation, 6 months after post-intervention
Secondary outcome [4] 351387 0
Psychological distress - DHQ5 (Distress Questionnaire 5)
Timepoint [4] 351387 0
7 weeks post-randomisation, 6 months after post-intervention
Secondary outcome [5] 351388 0
Suicidal ideation as assessed by (PSF) Symptom Frequency Scale – suicide items
Timepoint [5] 351388 0
7 weeks post-randomisation, 6 months after post-intervention
Secondary outcome [6] 351389 0
Disability/days out of role (2 questions): 1. In he last 30 days, how many days were you totally unable to work, study, or manage your day-to-day activities because of emotional problems (such as feeling depressed or anxious)?; 2. Aside from those days, in the last 30 days, how many days were you able to work, study, or manage your day-to-day activities but had to cut back on what you did or did not get as much done as usual because of emotional problems?
Timepoint [6] 351389 0
7 weeks, 6 months after post-intervention
Secondary outcome [7] 351390 0
Quality of Life - EURO-HIS-QOL 8
Timepoint [7] 351390 0
7 weeks, 6 months after post-intervention

Eligibility
Key inclusion criteria
1) Symptoms of depression OR anxiety in the mild to moderate range (PHQ-9 OR GAD-7 score at screening of 5-14).
2) Aged 18 years or over and living in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Previous use of the myCompass online program.
2) Receiving psychological therapy at screening.
3) Had a suicide plan in the past month.
4) Diagnosis of psychosis or bipolar disorder.
5) Symptoms of depression AND anxiety in the none/low range (PHQ-9 AND GAD-7 score at screening of 0-4).
6) Symptoms of depression OR anxiety in the severe range (PHQ-9 OR GAD-7 score at screening of 15+).

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 conducted by automatic computer generated randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to one of the three conditions, using stratified randomisation on symptom severity (as measured by the DQ5 at baseline), age, and gender (permuted block randomisation, block size of 6 within each stratum) to ensure balance across conditions using a computerised randomisation algorithm embedded into the trial portal.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We aim to recruit a total sample of N = 693 (n=231 per condition) from the online recruitment based on the following calculations. For the primary outcomes, to detect increases in uptake from 50% to 65% (a conservative baseline and increase) with 90% power requires a sample of 231 per condition (with =.05). To detect increases in adherence, assuming a small effect of f=0.19 (the estimated median effect) between active conditions requires a sample of 111 per condition. For the secondary outcomes, a sample of 110 per condition is required to find a small effect size of f=0.18 between active conditions relative to control over three assessments (baseline, post, 6 months follow-up) with 90% power (=.05, r=0.5 between repeated measures). For assessing differences in efficacy outcomes, up to 30% attrition from post-test assessments would require a target sample of 158 per condition. Based on the largest estimate of N required (n=231 per condition), we aim to recruit a total sample of N=693.

Primary outcomes: Uptake will be assessed as the number of individuals who access at least one therapeutic module of the program. Rates of uptake in myCompass + AFI will be compared to uptake in the myCompass Alone condition, based on a chi-square test, as complete data on uptake will be available for all individuals randomised to the active conditions. Online usage data is automatically collected by the myCompass program for each user. We will explore secondary indices of adherence (e.g., percentage of users completing one/half/all modules) for consistency of outcomes, and examine self-reported reasons for non-adherence. To test the effect of the AFI on adherence, module completion in myCompass + AFI will be compared to module completion in the myCompass Alone condition using a Mann-Whitney test, based on usage data as above.

Secondary outcomes: Analysis of the relative efficacy of the myCompass + AFI condition to the myCompass Alone condition will be conducted with respect to change over time (pre-test to post-test and pre-test to follow-up) relative to the control condition. Intention-to-treat analyses will be conducted using mixed model repeated measures estimates, conservatively estimated using unstructured covariance matrices.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2018
Actual
14/01/2019
Date of last participant enrolment
Anticipated
30/06/2019
Actual
21/03/2019
Date of last data collection
Anticipated
9/11/2019
Actual
18/11/2019
Sample size
Target
698
Accrual to date
Final
849
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300461 0
Government body
Name [1] 300461 0
National Health and Medical Research Council (NHMRC)
Country [1] 300461 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Philip Batterham
Address
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country
Australia
Secondary sponsor category [1] 299930 0
None
Name [1] 299930 0
Address [1] 299930 0
Country [1] 299930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301264 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 301264 0
Ethics committee country [1] 301264 0
Australia
Date submitted for ethics approval [1] 301264 0
17/04/2018
Approval date [1] 301264 0
14/05/2018
Ethics approval number [1] 301264 0
Protocol 2018/257

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86414 0
A/Prof Philip Batterham
Address 86414 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 86414 0
Australia
Phone 86414 0
+61 2 6125 1031
Fax 86414 0
Email 86414 0
[email protected]
Contact person for public queries
Name 86415 0
Amelia Gulliver
Address 86415 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 86415 0
Australia
Phone 86415 0
+61 2 6125 9472
Fax 86415 0
Email 86415 0
[email protected]
Contact person for scientific queries
Name 86416 0
Amelia Gulliver
Address 86416 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 86416 0
Australia
Phone 86416 0
+61 2 6125 9472
Fax 86416 0
Email 86416 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
4178Study protocolBatterham PJ, Calear AL, Sunderland M, Kay-Lambkin F, Farrer LM, Gulliver A. A brief intervention to increase uptake and adherence of an online program for depression and anxiety: Protocol for the Enhancing Engagement with Psychosocial Interventions (EEPI) Randomized Controlled Trial. Contemp Clin Trials. 2019 Mar;78:107-115. doi: 10.1016/j.cct.2019.01.015. Epub 2019 Jan 31. PubMed PMID: 30711664.  
19666Data dictionary    375839-(Uploaded-26-06-2023-12-59-03)-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
SourceTitleYear of PublicationDOI
EmbaseA brief intervention to increase uptake and adherence of an online program for depression and anxiety: Protocol for the Enhancing Engagement with Psychosocial Interventions (EEPI) Randomized Controlled Trial.2019https://dx.doi.org/10.1016/j.cct.2019.01.015
EmbaseA brief intervention to increase uptake and adherence of an internet-based program for depression and anxiety (Enhancing Engagement with Psychosocial Interventions): Randomized controlled trial.2021https://dx.doi.org/10.2196/23029
EmbasePredictors of acceptability and engagement in a self-guided online program for depression and anxiety.2021https://dx.doi.org/10.1016/j.invent.2021.100400
N.B. These documents automatically identified may not have been verified by the study sponsor.