Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000407796
Ethics application status
Approved
Date submitted
10/04/2013
Date registered
15/04/2013
Date last updated
30/06/2024
Date data sharing statement initially provided
25/11/2019
Date results provided
17/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The MindSpot Clinic: Telephone and internet-delivered psychological assessment and treatment for Australians with symptoms of anxiety and depression
Scientific title
The MindSpot Clinic:: Telephone and internet-delivered psychological assessment and treatment for Australians with symptoms of anxiety and depression
Secondary ID [1] 282290 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 288827 0
Anxiety 288828 0
Condition category
Condition code
Mental Health 289182 289182 0 0
Depression
Mental Health 289183 289183 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MindSpot Clinic is national mental health service that provides telephone and internet assessment and treatment of Australians with anxiety or depression. Prospective participants and/or inquiries can be made via the website:

mindspot.org.au

MindSpot treatment courses comprise 5 lessons which are provided online, electronically, or sent via post. Mode of administration is based on participant preference. Lessons describe evidence-based cognitive behavioural and interpersonal therapy strategies for managing cognitive, behavioural, and physical symptoms of anxiety and low mood. One lesson will be completed every 1 to 3 weeks. Each lesson will take about 15 minutes to read. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with anxiety and low mood, taking a further 20 minutes per week. All participants will also receive 10-20 automatic emails to promote adherence and engagement, and at least weekly written or telephone contact from a therapist at the MindSpot Clinic.
Intervention code [1] 286916 0
Behaviour
Intervention code [2] 286934 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289292 0
Severity of psychological distress is measured by the Kessler 10-item (K-10) scale.
Timepoint [1] 289292 0
Administered at assessment (when participants initially apply to join a course), pre-intervention (immediately prior to the course), post-intervention, and at 3-months post-intervention. The pre-intervention time-point may occur up several days or weeks after the assessment time-point.
Primary outcome [2] 289293 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [2] 289293 0
Administered at assessment, pre-intervention, at the beginning of each week of the Course, post-intervention, and at 3-months post-intervention.
Primary outcome [3] 289294 0
Symptoms of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [3] 289294 0
Administered at assessment, pre-intervention, post-intervention, and at 3-months post-intervention.
Secondary outcome [1] 302180 0
Symptoms and severity of obsessive compulsive disorder are measured by the Yale Brown Obsessive Compulsive Scale - Self Report (YBOCS-SR).
Timepoint [1] 302180 0
Administered at assessment, pre-intervention, mid-intervention, post-intervention, and at 3-months post-intervention.
Secondary outcome [2] 302181 0
Symptoms and severity of post-traumatic stress disorder are measured by the PTSD Checklist (PCL).
Timepoint [2] 302181 0
Administered at assessment, pre-intervention, mid-intervention, post-intervention, and at 3-months post-intervention.

Eligibility
Key inclusion criteria
1. 18+ years of age
2. Provides informed consent
3. Resident of Australia
4. Presenting problem are symptoms of an anxiety disorder or depressive disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presenting problem not anxiety or depression
2. Receiving psychological therapy for target symptoms at same time as the present trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will contact the MindSpot Clinic, read about the study, and will decide whether or not to provide Informed Consent.

Those who provide Informed Consent will complete a telephone or online assessment that comprises questionnaires of symptoms of depression and anxiety, the Patient Health Questionnaire-9 Item and Generalised Anxiety Disorder-7 item questionnaires, respectively. Potential participants will also be asked to complete demographic questionnaires.

Potential participants will be informed about MindSpot Clinic Treatment Courses and will decide whether or not to participate. Participants who meet eligibility criteria will be given access codes to begin the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Because of the observational nature of the aims of this study, formal analyses of sample size have not been conducted. However, it is anticipated consecutive cohorts of 100-200 participants will be analysed, for purposes of exploring changes in effectiveness as the service develops.

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
Completed
Date of first participant enrolment
Anticipated
16/04/2013
Actual
16/04/2013
Date of last participant enrolment
Anticipated
30/06/2023
Actual
11/08/2022
Date of last data collection
Anticipated
11/08/2023
Actual
11/08/2023
Sample size
Target
40000
Accrual to date
Final
200000
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287055 0
Government body
Name [1] 287055 0
Department of Health
Country [1] 287055 0
Australia
Funding source category [2] 287056 0
University
Name [2] 287056 0
Macquarie University
Country [2] 287056 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 285837 0
None
Name [1] 285837 0
Address [1] 285837 0
Country [1] 285837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289084 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289084 0
Ethics committee country [1] 289084 0
Australia
Date submitted for ethics approval [1] 289084 0
Approval date [1] 289084 0
03/12/2012
Ethics approval number [1] 289084 0
5201200912

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

Contacts
Principal investigator
Name 39158 0
Prof Nickolai Titov
Address 39158 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 39158 0
Australia
Phone 39158 0
+61 2 98509901
Fax 39158 0
Email 39158 0
nick.titov@mq.edu.au
Contact person for public queries
Name 39159 0
Assoc Prof Lauren Staples
Address 39159 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 39159 0
Australia
Phone 39159 0
+612 9805 3000
Fax 39159 0
Email 39159 0
lauren.staples@mq.edu.au
Contact person for scientific queries
Name 39160 0
Assoc Prof Lauren Staples
Address 39160 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 39160 0
Australia
Phone 39160 0
+612 9805 3000
Fax 39160 0
Email 39160 0
lauren.staples@mq.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?
Access to de-identified 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 lauren.staples@mq.edu.au


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
SourceTitleYear of PublicationDOI
EmbaseAntidepressant medication use by patients accessing a national digital mental health service.2022https://dx.doi.org/10.1016/j.jad.2022.04.042
EmbaseEvaluation of a therapist-guided virtual psychological pain management program when provided as routine care: a prospective pragmatic cohort study.2023https://dx.doi.org/10.1093/pm/pnad102
EmbasePredictors of functional impairment at assessment and functional improvement after treatment at a national digital mental health service.2023https://dx.doi.org/10.1016/j.invent.2023.100603
N.B. These documents automatically identified may not have been verified by the study sponsor.