Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001160628
Ethics application status
Approved
Date submitted
13/08/2023
Date registered
9/11/2023
Date last updated
9/11/2023
Date data sharing statement initially provided
9/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Storage of Digital Mental Health Data for Research: MindSpot Research Databank
Scientific title
Longitudinal collection of Digital Mental Health Data (health information and treatment outcomes) for Research: MindSpot Research Databank
Secondary ID [1] 310377 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 331117 0
Depression 331118 0
Condition category
Condition code
Mental Health 327900 327900 0 0
Anxiety
Mental Health 327901 327901 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The MindSpot Clinic (www.mindspot.org.au) is a national digital mental health service (DMHS) funded by the Australian Federal Government’s Department of Health and established in December 2012. MindSpot provides psychological information, assessment, and treatment to Australian adults with common mental health disorders, via the internet and telephone. Patients can access MindSpot directly via the website or be referred by their health professional. Patient data, including demographics, health information, and treatment outcomes, is routinely collected by MindSpot in accordance with Australian Privacy Principles for highly sensitive health information. The primary purpose of the MindSpot Research Databank is to allow data that is gathered as part of the routine operations of MindSpot to be stored in deidentified format for research purposes.

People register with MindSpot by creating an account and completing a screening assessment, online or by telephone. The screening assessment includes questions on demographics, previous health service use information, symptoms, and current stressors. It takes about 20 minutes to complete. Participants who complete an assessment may then elect to enrol in a MindSpot digital treatment course, which consists of 5 online lessons delivered over 8 weeks. Or they may enrol for Teletherapy, which consists of approximately 4-5 sessions of therapy delivered via the telephone. For all treatment options, treatment engagement is monitored, and standardised symptom measures are administered to allow symptom improvements to be measured. The primary symptom measure is the K-10, which is a 10-item measure of psychological distress. Treatment outcomes are measures at the start of treatment, mid-treatment, post-treatment, and at 3-month follow-up. Participants who enrolled in treatment will only be followed up for 3 months post-program participation however they will be asked to consent to their data being used for future analyses, noting that no new data will be requested for these analyses. Participants who participate in the assessment only (i.e., do not participate in any treatments offered by MindSpot), the duration of observation ends at this point (i.e., once-off participation).



Intervention code [1] 326834 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335745 0
The Kessler Psychological Distress 10-Item Scale (K-10), is a standardised quantitative scale consisting of ten items which measure general psychological distress.
Timepoint [1] 335745 0
Administered at assessment, pre-treatment (immediately prior to the course), mid-treatment, post-treatment, and at 3-months post-treatment.
Primary outcome [2] 335746 0
The Patient Health Questionnaire-9 (PHQ-9) consists of nine items measuring symptoms
of major depressive disorder according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
Timepoint [2] 335746 0
Administered at assessment, pre-treatment (immediately prior to the course), mid-treatment, post-treatment, and at 3-months post-treatment.
Primary outcome [3] 335749 0
Generalized Anxiety Disorder 7-Item Scale (GAD-7) consists of seven items and is used to screen for the presence of generalised anxiety.
Timepoint [3] 335749 0
Administered at assessment, pre-treatment (immediately prior to the course), mid-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 425829 0
Nil
Timepoint [1] 425829 0
Nil

Eligibility
Key inclusion criteria
1. 16+ years of age
2. Provides informed consent
3. Resident of Australia
4. Symptoms of anxiety or depression
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presenting problem not primarily anxiety or depression,

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Because of the observational nature of the data, formal analyses of sample size have not been conducted. Analyses will be conducted using parametric techniques and intention-to-treat and completer models, and will include tests of clinically significant change.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/08/2022
Date of last participant enrolment
Anticipated
11/08/2027
Actual
Date of last data collection
Anticipated
11/02/2028
Actual
Sample size
Target
100000
Accrual to date
20000
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314578 0
Government body
Name [1] 314578 0
Department of Health and Aged Care
Country [1] 314578 0
Australia
Funding source category [2] 314579 0
University
Name [2] 314579 0
Macquarie University
Country [2] 314579 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
North RydeNSW 2109
Country
Australia
Secondary sponsor category [1] 316541 0
None
Name [1] 316541 0
Address [1] 316541 0
Country [1] 316541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313614 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 313614 0
Ethics committee country [1] 313614 0
Australia
Date submitted for ethics approval [1] 313614 0
11/07/2022
Approval date [1] 313614 0
12/08/2022
Ethics approval number [1] 313614 0
520221101840066

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

Contacts
Principal investigator
Name 128750 0
Prof Nickolai Titov
Address 128750 0
Macquarie University
North Ryde
NSW 2109
Country 128750 0
Australia
Phone 128750 0
+61 2 98509901
Fax 128750 0
Email 128750 0
[email protected]
Contact person for public queries
Name 128751 0
Lauren Staples
Address 128751 0
Macquarie University
North Ryde
NSW 2109
Country 128751 0
Australia
Phone 128751 0
+61 2 98509901
Fax 128751 0
Email 128751 0
[email protected]
Contact person for scientific queries
Name 128752 0
Lauren Staples
Address 128752 0
Macquarie University
North Ryde
NSW 2109
Country 128752 0
Australia
Phone 128752 0
+61 2 98509901
Fax 128752 0
Email 128752 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?
Access to deidentified data may be provided for the purpose of verifying published findings. Access may be provided to researchers subject to a formal written request, the generation of a methodologically sound research protocol, the establishment of appropriate data governance, and the approval of an independent and recognised Human Research Ethics Committee.
When will data be available (start and end dates)?
Immediately following publication, no end date specified
Available to whom?
Researchers subject to conditions outlined above
Available for what types of analyses?
Not specified
How or where can data be obtained?
Access subject to approvals. Please send written requests to A/Prof Lauren Staples, at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.