Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000035820
Ethics application status
Approved
Date submitted
6/01/2012
Date registered
9/01/2012
Date last updated
29/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Web-based Intervention for Employees with Depression
Scientific title
Investigation of the therapeutic outcomes associated with web-based intervention for employed persons with low mood and low work productivity.
Secondary ID [1] 279673 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 285494 0
Work productivity (work absenteeism and presenteeism) 285509 0
Condition category
Condition code
Mental Health 285681 285681 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Finding the Balance was developed to provide information and assistance to people who are currently employed and experiencing a low mood. The program involves 8 modules over 8 weeks provided in an online format. Participants are provided behavioural and cognitive (i.e., thinking) strategies to assist in improving their mood. It is anticipated that the online group will spend approximate 30 to 60 minutes to complete each module per week.
Intervention code [1] 283963 0
Treatment: Other
Intervention code [2] 283977 0
Treatment: Devices
Intervention code [3] 283978 0
Behaviour
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286220 0
Depression will be measured by scores on the Patient Health Questionnaire (PHQ; Spitzer, Kroenke, & Williams, 1999) and Mini International Neuropsychiatric Interview (M.I.N.I.) Version 6.0.0.
Timepoint [1] 286220 0
Participant will complete the PHQ pre-treatment, during treatment at fortnightly intervals (2, 4, 6 and 8-week) and post-treatment at 12 and 24 weeks. The MINI 6.0.0 will be completed at pre-treatment and post-treatment at 12 and 24-weeks.
Secondary outcome [1] 295406 0
Work productivity will be measured by the Health and Performance Questionnaire (HPQ).
Timepoint [1] 295406 0
Administered pre-treatment, during treatment (6 weeks), post-treatment (12 weeks and 24 weeks)

Eligibility
Key inclusion criteria
1. Depression score on or above 10 as measured by the Patient Health Questionnaire-9 (PHQ-9). This cut-off was chosen based on a previous study conducted by Kroenke, Spitzer, and Williams (2001) investigating the validity of the PHQ-9. Kroenke et al. found persons who scored 10 or above were representative of those clients who were diagnosed with major depression. 2. Participants will have to be employed and have been working for the past 4 weeks. Participants can be employed on a casual, contract, part-time, or full-time basis. 3. Participants will need to agree to complete questionnaires during and after treatment. 4. Participants will need to be able to read and understand English to a Grade 7 level. 5. Participants will need to have access to the internet and have an email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. If the participant scores above 15 on the Alcohol Use and Dependence Identification Test (AUDIT). 2. If the participant meets diagnosis for Psychotic Disorders including Mood Disorder with Psychotic Features as measured by the M.I.N.I. 6.0.0. 3. If the participant is currently receiving psychological treatment. 4. If the participant is currently undergoing a work injuries claim.

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)
delete last sentence as no longer randomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
again non-randomised trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
non-randomised trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284454 0
University
Name [1] 284454 0
Griffith University
Country [1] 284454 0
Australia
Primary sponsor type
Individual
Name
Dr Leanne Casey
Address
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mount Gravatt, QLD 4111
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286432 0
Griffith University Research Ethics Committee
Ethics committee address [1] 286432 0
Research Ethics
Office for Research
Gold Coast Campus, Griffith University
Gold Coast, QLD 4222
Ethics committee country [1] 286432 0
Australia
Date submitted for ethics approval [1] 286432 0
Approval date [1] 286432 0
21/07/2010
Ethics approval number [1] 286432 0
PSY90/10/HREC

Summary
Brief summary
The aim of this study is to develop a Cognitive-Behavioural Therapy, web-based intervention for depression for employed people, and then apply it to a group of employed participants to determine whether this assists with recovery from depression and increase work productivity. It is expected that participants will show improvement in depressive symptoms and increased work productivity from pre- to post-treatment intervention.
Trial website
www.findingthebalance.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33587 0
Dr Dr Leanne Casey
Address 33587 0
School of Psychology Griffith University, Mt Gravatt Campus 176 Messines Ridge Road Mt Gravatt, Qld 4111
Country 33587 0
Australia
Phone 33587 0
+61 7 37353314
Fax 33587 0
Email 33587 0
[email protected]
Contact person for public queries
Name 16834 0
Dr Dr Leanne Casey
Address 16834 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld 4111
Country 16834 0
Australia
Phone 16834 0
61 7 3735 3314
Fax 16834 0
Email 16834 0
[email protected]
Contact person for scientific queries
Name 7762 0
Dr Dr Leanne Casey
Address 7762 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld 4111
Country 7762 0
Australia
Phone 7762 0
61 7 3735 3314
Fax 7762 0
Email 7762 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.