Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000324617
Ethics application status
Approved
Date submitted
28/02/2014
Date registered
26/03/2014
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial for the effect of symptom feedback on help-seeking for mental health issues.
Scientific title
A randomised controlled trial for the effect of symptom feedback on help-seeking for mental health issues in the general public.
Secondary ID [1] 284090 0
Nil
Universal Trial Number (UTN)
U1111-1153-3028
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking 291164 0
Mental health issues 291432 0
Condition category
Condition code
Public Health 291496 291496 0 0
Health promotion/education
Mental Health 291802 291802 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants from a larger validation study of mental health screening questionnaires will also be able to opt in to a low-intensity randomised controlled trial providing feedback about their symptoms. In the trial, participants will get feedback about their symptoms (intervention condition) or general feedback about symptoms in the population (control condition). This feedback will be for either depression symptoms, adult ADHD, or social phobia, depending on which screener is presented in the larger validation study. The feedback will be provided to the participants in the intervention online on a single screen. Prior to the feedback, participants will complete a brief set of questions on quality of life and service use. Following the feedback, participants will then complete another brief survey 3 months later. Respondents who choose to participate in the trial will only be identifiable through their provision of an email address.
Intervention code [1] 288784 0
Early detection / Screening
Comparator / control treatment
Active control: participants in the control condition will receive general feedback about symptoms in the population.
Control group
Active

Outcomes
Primary outcome [1] 291472 0
Help-seeking behaviour (AHSQ: Actual Help-Seeking Questionnaire).
Timepoint [1] 291472 0
3 months
Secondary outcome [1] 306847 0
Help-seeking intentions (GHSQ: General Help-Seeking Questionnaire).
Timepoint [1] 306847 0
3 months

Eligibility
Key inclusion criteria
All participants who opt-in for participation by providing their email address. These participants will be from a larger national validation study of mental health screening questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be able to opt-in for participation in the study after completing a large survey of mental health screening questionnaires. Allocation will be concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (within limesurvey).
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
Efficacy
Statistical methods / analysis
In the Australian general population 11.9% of people seek help for a mental disorder in a 12-month period. However, 20% meet criteria for a disorder and substantially more have mental health problems. The feedback intervention aims to reduce the service gap by 30%, i.e., increase overall helpseeking from 11.9% to 15.5%. To find such a difference with 85% power, we will require 3372 participants (1686 in each condition across the three disorders of interest). The study will also have 90% power to find small differences (d > 0.10) in help seeking intentions between intervention and control groups overall, and to find small differences (d > 0.17) between intervention and control groups within the three disorders of interest.

Binary mixed effects repeated measures models will be used to analyse the help seeking outcomes, following an intention to treat approach under the missing at random assumption.

Burgess, P. M., Pirkis, J. E., Slade, T. N., Johnston, A. K., Meadows, G. N., & Gunn, J. M. (2009). Service use for mental health problems: findings from the 2007 National Survey of Mental Health and Wellbeing. Australian and New Zealand Journal of Psychiatry, 43(7), 615-623.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2014
Actual
1/08/2014
Date of last participant enrolment
Anticipated
24/04/2015
Actual
19/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
3372
Accrual to date
Final
2773
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288732 0
Government body
Name [1] 288732 0
National Health and Medical Research Council
Country [1] 288732 0
Australia
Primary sponsor type
University
Name
The Centre for Mental Health Research, The Australian National University
Address
Building 63
Mills Road
Acton ACT 0200
Country
Australia
Secondary sponsor category [1] 287430 0
University
Name [1] 287430 0
National Drug and Alcohol Research Centre at the University of New South Wales
Address [1] 287430 0
NDARC
University of New South Wales
Sydney NSW 2052, Australia
Country [1] 287430 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294201 0
ANU Science & Medical Delegated Ethics Review Committee
Ethics committee address [1] 294201 0
Ethics committee country [1] 294201 0
Australia
Date submitted for ethics approval [1] 294201 0
23/08/2013
Approval date [1] 294201 0
27/09/2013
Ethics approval number [1] 294201 0
2013/509

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

Contacts
Principal investigator
Name 46242 0
Dr Philip Batterham
Address 46242 0
The Centre for Mental Health Research
The Australian National University
Building 63
Mills Road
ACTON ACT 0200
Country 46242 0
Australia
Phone 46242 0
+61 2 6125 1031
Fax 46242 0
Email 46242 0
[email protected]
Contact person for public queries
Name 46243 0
Jacqueline Brewer
Address 46243 0
The Centre for Mental Health Research
The Australian National University
Building 63
Mills Road
ACTON ACT 0200
Country 46243 0
Australia
Phone 46243 0
+61 2 6125 7122
Fax 46243 0
Email 46243 0
[email protected]
Contact person for scientific queries
Name 46244 0
Philip Batterham
Address 46244 0
The Centre for Mental Health Research
The Australian National University
Building 63
Mills Road
ACTON ACT 0200
Country 46244 0
Australia
Phone 46244 0
+61 2 6125 1031
Fax 46244 0
Email 46244 0
[email protected]

No information has been provided regarding IPD availability


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.