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Trial registered on ANZCTR


Registration number
ACTRN12608000262303
Ethics application status
Approved
Date submitted
20/05/2008
Date registered
22/05/2008
Date last updated
22/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Work Outcomes Research Cost-benefit project
Scientific title
Full-time employees, a telephone intervention to increase engagement in treatment for depression; a comparison between a single contact and multiple contacts; productivity outcome measures: absenteeism & presenteesim, treatment engagement; severity of depressive symptom scores.
Universal Trial Number (UTN)
Trial acronym
The WORC project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 3170 0
Condition category
Condition code
Mental Health 3328 3328 0 0
Depression
Public Health 3329 3329 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proactive screening and identification of full time employees with untreated symptoms of depression and provision of either a single or multiple telephone contacts to increase engagement in treatment. Recruitment of full-time emp0lyee particpants occurred between October 2004 and March 2006. Data collection continued to October 2007. Participants in the multiple contact condition received an average of 8.7 telephone contacts in addition to the single contact. However, the number of contacts was allowed to vary on the basis of clinical judgment of severity of symptoms and need. These contacts focused on addressing the participant's barriers to treatment. Once the participant indicated that they had seen a health professional specifically for their emotional/psychological symptoms, the focus of the contacts shifted to monitoring progress and addressing concerns the person might have with their progress in treatment. Depression is often characterised by cognitions of hopelessness and helplessness; cognitive behavioral therapy (CBT) in addition to motivational interviewing strategies were used by the psychologists to address these issues. People who could not access in person services or who refused in person treatment were offered telephone CBT to assist with their depressive symptoms.
Intervention code [1] 2900 0
Early detection / Screening
Intervention code [2] 2901 0
Treatment: Other
Comparator / control treatment
Single telephone contact
Control group
Dose comparison

Outcomes
Primary outcome [1] 4215 0
Reported seeking treatment specifically for emotional and/or psychological difficulties
Timepoint [1] 4215 0
6-weeks; 3, 6, 12, 18-months following baseline
Primary outcome [2] 4216 0
Productivity in terms of absenteeism; 'presenteeism'; job retention; promotions and demotions
Timepoint [2] 4216 0
6-weeks; 3, 6, 12, 18-months following baseline
Secondary outcome [1] 7133 0
Reported depression symptom severity using two measures: The Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) (Rush et al., 2003) and, The Patient Health Questionnaire-9 (PHQ-9, Spitzer et al., 1999). The QIDS-SR was administered by blinded external assessors at each survey time: baseline (Wave1), and post verbal consent at 6-weeks (Wave 2), 3-months (Wave 3), 6-months (Wave 4), 12-months (Wave 5)and 18-months (Wave 6).
Timepoint [1] 7133 0
6-weeks; 3, 6, 12, 18-months following baseline

Eligibility
Key inclusion criteria
Full-time employment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Alcohol and Drug dependence; Mania; Psychosis; in current treatment

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 involved two concealed steps. The baseline QIDS-SR and PHQ-9 was delivered by trained survey interviewers at an external contracted call centre service conducting the telephone interviews. The data from eligible participants was then transferred to the senior clinical psychologist who supervised the psychology/care manger team in making the initial single contact with all eligible participants. Following successful contact with a participant, the care manger psychologists, who had conducted the single contact and determined eligibility, returned the file to the senior psychologist who then gave the participant information to a non-clinical research assistant who was located at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was carried out following the single contact (SC) and verbal consent procedure by a non-clinical research assistant using a random number generation randomisation table for each site (employer) yielding different orders for each site with the exception of those participants who had been assessed for suicide risk.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3399 0
Government body
Name [1] 3399 0
Department of Health and Aging
Country [1] 3399 0
Australia
Funding source category [2] 3400 0
Government body
Name [2] 3400 0
Queensland Health
Country [2] 3400 0
Australia
Funding source category [3] 3401 0
Charities/Societies/Foundations
Name [3] 3401 0
beyondblue:the national depression initiative
Country [3] 3401 0
Australia
Funding source category [4] 3402 0
Charities/Societies/Foundations
Name [4] 3402 0
The Australian Rotary Health Research Fund
Country [4] 3402 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Brisbane, QLD
Country
Australia
Secondary sponsor category [1] 3046 0
Government body
Name [1] 3046 0
Department of Health and Aging
Address [1] 3046 0
Canberra, ACT
Country [1] 3046 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5428 0
Human Research Ethics Committee
Ethics committee address [1] 5428 0
University of Queensland, St Lucia, QLD
Ethics committee country [1] 5428 0
Australia
Date submitted for ethics approval [1] 5428 0
Approval date [1] 5428 0
25/08/2004
Ethics approval number [1] 5428 0
2004000304
Ethics committee name [2] 5429 0
Queensland Human Research Ethics Committee
Ethics committee address [2] 5429 0
Brisbane, QLD
Ethics committee country [2] 5429 0
Australia
Date submitted for ethics approval [2] 5429 0
Approval date [2] 5429 0
20/09/2004
Ethics approval number [2] 5429 0
E/9/2004
Ethics committee name [3] 5430 0
Departmental Ethics Committee
Ethics committee address [3] 5430 0
Department of Health and Aging, Canberra, ACT
Ethics committee country [3] 5430 0
Australia
Date submitted for ethics approval [3] 5430 0
Approval date [3] 5430 0
01/08/2005
Ethics approval number [3] 5430 0
Application 4/2005
Ethics committee name [4] 5431 0
Justice Research Ethics Committee
Ethics committee address [4] 5431 0
GPO Box 43566QQ
Melbourne, VIC, 3002
Ethics committee country [4] 5431 0
Australia
Date submitted for ethics approval [4] 5431 0
Approval date [4] 5431 0
31/01/2005
Ethics approval number [4] 5431 0
EC/04/32 ? The WORC Project

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

Contacts
Principal investigator
Name 28601 0
Address 28601 0
Country 28601 0
Phone 28601 0
Fax 28601 0
Email 28601 0
Contact person for public queries
Name 11758 0
Dr Michael Hilton
Address 11758 0
Queensland Centre for Mental Health Research,
The Park- Centre for Mental Health Research, Treatment and Rehabilitation, Wacol, Brisbane, 4076
Country 11758 0
Australia
Phone 11758 0
+61 7 32718666
Fax 11758 0
Email 11758 0
michael_hilton@qcmhr.uq.edu.au
Contact person for scientific queries
Name 2686 0
Professor Harvey WHiteford
Address 2686 0
Queensland Centre for Mental Health Research,
The Park- Centre for Mental Health Research, Treatment and Rehabilitation, Wacol, Brisbane, 4076
Country 2686 0
Australia
Phone 2686 0
+61 7 32718684
Fax 2686 0
Email 2686 0
Harvey Whiteford [h.whiteford@sph.uq.edu.au]

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

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