Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000792527
Ethics application status
Approved
Date submitted
17/07/2015
Date registered
30/07/2015
Date last updated
13/03/2019
Date data sharing statement initially provided
13/03/2019
Date results information initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Contact&Connect: A randomised trial of a multimedia-based mental health wellbeing program for unemployed construction workers.
Scientific title
Contact&Connect: A randomised trial of a multimedia-based mental health wellbeing program to improve mental health literacy, depression, and suicidality in unemployed construction workers.
Secondary ID [1] 287105 0
None.
Universal Trial Number (UTN)
U1111-1172-2557.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression stigma. 295629 0
Mental health literacy. 295630 0
Suicidality. 295631 0
Help-seeking behaviour. 295632 0
Condition category
Condition code
Mental Health 295908 295908 0 0
Depression
Mental Health 295909 295909 0 0
Suicide
Mental Health 295975 295975 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contact&Connect is a multimedia-based package of brief contact interventions (BCIs). These will be delivered to participants as rich text messages with embedded hyperlinks to microsites, videos, electronic passbooks, and digital wallet cards that provide basic information to improve mental health literacy and encouragement to connect socially with others through the use of “reward tokens”. Participants will also be provided with an electronic passbook containing information on emergency contacts.

Although content will be developed through qualitative focus group sessions with members of the construction industry and in collaboration with our partner organisation, Incolink, to ensure the resources are appropriate and acceptable to participants, BCIs will be delivered as structured contacts that seek to provide support, education and maintain long-term contact with individuals. The intervention will largely be educational with content flowing across three main themes: de-bunking myths and stereotypes, normalisation, and empowerment.

The Contact&Connect intervention will be delivered over six weeks. Participants receive two BCIs in the first week, then receive one a week for five weeks. Monitored usage of the embedded hyperlinks will be used to monitor adherence throughout the intervention.
Intervention code [1] 292350 0
Prevention
Intervention code [2] 292408 0
Behaviour
Comparator / control treatment
Attention placebo comprising rich text messages with embedded hyperlinks to microsites that provide participants with information on the diagnosis and management of physical illnesses and injuries.
Control group
Placebo

Outcomes
Primary outcome [1] 295583 0
Shame, self-blame and social inadequacy measured using the Self Stigma of Depression Scale (SSDS), excluding the help-seeking subscale. We collapsed the options for responding to each item from 1 to 5 to 1 to 4 (representing strongly agree, agree, disagree, strongly disagree).
Timepoint [1] 295583 0
6 weeks
Secondary outcome [1] 333543 0
Suicidal ideation and attempts were measured using the Suicidal Behaviors Questionnaire-Revised (SBQ-R) (Osman et al., 2001)
Timepoint [1] 333543 0
6 weeks

Eligibility
Key inclusion criteria
Construction workers who are currently unemployed and own a smart phone with enabled internet connectivity and adequate data download capacity are eligible. Those who are eligible are registered with Incolink (a social welfare trustee company that provides support to unemployed members of the construction industry). The intervention is primarily aimed at males. However, because of strong interest from females, these participants are also included and analyzed separately in sensitivity analysis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those excluded from the study were people not in possession of a smart phone with enabled internet connectivity with adequate data download capacity, and those with insufficient English language ability. We will analyse females as a sensitivity analyses, as we found number of them were interested in taking part in the study. We did not exclude any construction worker on the basis of age

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)
Allocation by offsite researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
15/03/2016
Date of last participant enrolment
Anticipated
16/04/2017
Actual
12/04/2017
Date of last data collection
Anticipated
22/06/2017
Actual
13/07/2017
Sample size
Target
452
Accrual to date
Final
468
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291663 0
Charities/Societies/Foundations
Name [1] 291663 0
Beyond Blue.
Country [1] 291663 0
Australia
Primary sponsor type
University
Name
Deakin University.
Address
221 Burwood Highway, Burwood, Victoria, 3125.
Country
Australia
Secondary sponsor category [1] 290337 0
Charities/Societies/Foundations
Name [1] 290337 0
Incolink.
Address [1] 290337 0
1 Pelham Street, Carlton, Victoria, 3035.
Country [1] 290337 0
Australia
Secondary sponsor category [2] 295014 0
University
Name [2] 295014 0
University of Melbourne
Address [2] 295014 0
207 Bouverie Street, Carlton, Victoria 3010
Country [2] 295014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293190 0
Deakin University Human Research Ethics Committee (DUHREC).
Ethics committee address [1] 293190 0
221 Burwood Highway, Burwood, Victoria, 3125.
Ethics committee country [1] 293190 0
Australia
Date submitted for ethics approval [1] 293190 0
04/08/2015
Approval date [1] 293190 0
02/09/2015
Ethics approval number [1] 293190 0
2015-194
Ethics committee name [2] 297374 0
Human Ethics Advisory Group - School of Population and Global Health
Ethics committee address [2] 297374 0
School of Population and Global Health
Level 4, 207 Bouverie Street Carlton, Victoria, 3010
Ethics committee country [2] 297374 0
Australia
Date submitted for ethics approval [2] 297374 0
01/02/2017
Approval date [2] 297374 0
02/09/2015
Ethics approval number [2] 297374 0
TBD

Summary
Brief summary
Recent unemployment represents a significant risk factor for the development of mental health problems, such as depression, and suicidal behaviour. This relationship may be affected by age and gender with working age males at particular risk. Interventions which target recently unemployed working age males to reduce mental health stigma and improve mental health literacy skills may be effective in this population to reduce depression symptomatology and suicidal ideation.

The Contact&Connect intervention will be a series of digital ‘brief contact interventions’ (BCIs) with male unemployed construction workers aged 30-64 years. BCIs are defined a structured contacts using a variety of modalities that seek to provide support, education and maintain long-term contact with individuals. The BCIs will be delivered to workers’ smartphones via SMS rich text messages. These messages will include embedded hyperlinks to other digital resources the project will make available on the internet, including microsites, videos, and digital wallet cards. In terms of stigma reduction, the intervention will largely be educational. Content will flow across three main themes: de-bunking myths and stereotypes, normalisation, and empowerment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58854 0
Dr Allison Milner.
Address 58854 0
Centre for Health Equity, School of Population and Global Health, University of Melbourne. 207 Bouverie Street, Carlton 3010, Victoria
Country 58854 0
Australia
Phone 58854 0
+61 3 9251 7215.
Fax 58854 0
Email 58854 0
[email protected]
Contact person for public queries
Name 58855 0
Ms Caitlyn Wilson.
Address 58855 0
Incolink, 1 Pelham Street, Carlton, Victoria, 3035.
Country 58855 0
Australia
Phone 58855 0
+61 3 9668 3081.
Fax 58855 0
Email 58855 0
[email protected]
Contact person for scientific queries
Name 58856 0
Dr Allison Milner.
Address 58856 0
Melbourne School of Population and Global Health. The University of Melbourne. 235 Bouverie St, Carlton VIC 3053.
Country 58856 0
Australia
Phone 58856 0
+61 3 9251 7215.
Fax 58856 0
Email 58856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is owned jointly with another ogranisation


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Milner A, Law P, Witt K, LaMontagne AD, Mann C (20... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA smart-phone intervention to address mental health stigma in the construction industry: A two-arm randomised controlled trial.2018https://dx.doi.org/10.1016/j.ssmph.2017.12.007
EmbaseContact & connect--an intervention to reduce depression stigma and symptoms in construction workers: protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s12889-015-2394-x
N.B. These documents automatically identified may not have been verified by the study sponsor.