Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000114943
Ethics application status
Approved
Date submitted
31/01/2011
Date registered
1/02/2011
Date last updated
1/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of a low intensity intervention model within a university health service to improve the mental health of students.
Scientific title
A randomised trial of a low intensity intervention model within a university health service to improve the mental health of students.
Secondary ID [1] 253518 0
No secondary ID
Universal Trial Number (UTN)
U1111-1119-2540
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 261061 0
Condition category
Condition code
Mental Health 259209 259209 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Psychological Wellbeing practitioner will work with participants to develop a personalised intervention plan. Participants will receive a 15 minute telephone or skype consultation or email support with the practitioner each week for 8 weeks to help the participant problem solve any issues that arise and reinforce motivation to continue with the intervention. The intervention will use cognitive behavioural strategies.
Intervention code [1] 257942 0
Early detection / Screening
Intervention code [2] 257943 0
Behaviour
Intervention code [3] 257949 0
Treatment: Other
Comparator / control treatment
Participants in this condition will be sent an email with information on counselling and academic workshops available at their university. They will receive no other therapeutic contact.
Control group
Active

Outcomes
Primary outcome [1] 262052 0
A 5 unit reduction in depression symptoms as measured by DASS-21
Timepoint [1] 262052 0
2 months, 6 months, and 12 months
Secondary outcome [1] 273033 0
Reduction in student stress measured by University Stress Scale
Timepoint [1] 273033 0
2 months, 6 months, and 12 months
Secondary outcome [2] 273034 0
Increase in connectedness measured by the University Connectedness Scale
Timepoint [2] 273034 0
2 months, 6 months, and 12 months
Secondary outcome [3] 273035 0
Increase in wellbeing measured by the World Health Organisation Wellbeing Index
Timepoint [3] 273035 0
2 months, 6 months, and 12 months
Secondary outcome [4] 273036 0
Decrease in alcohol use measured by the AUDIT
Timepoint [4] 273036 0
2 months, 6 months, and 12 months

Eligibility
Key inclusion criteria
Enrolled students at The University of Queensland.
Clinically elevated scores on the K10
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently receiving services for mental health problems

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)
Computer generated invitation to participate in the study for students meeting inclusion criteria following screening of all students attending university health service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258408 0
Charities/Societies/Foundations
Name [1] 258408 0
Australian Rotary Health
Country [1] 258408 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia Qld 4072
Country
Australia
Secondary sponsor category [1] 257559 0
None
Name [1] 257559 0
Address [1] 257559 0
Country [1] 257559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260380 0
The University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 260380 0
Ethics committee country [1] 260380 0
Australia
Date submitted for ethics approval [1] 260380 0
Approval date [1] 260380 0
15/12/2010
Ethics approval number [1] 260380 0
2010001493

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

Contacts
Principal investigator
Name 32152 0
Address 32152 0
Country 32152 0
Phone 32152 0
Fax 32152 0
Email 32152 0
Contact person for public queries
Name 15399 0
Dr Helen Stallman
Address 15399 0
Schools of Medicine and Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
20 Cornwall Street
Woolloongabba, Qld 4102
Country 15399 0
Australia
Phone 15399 0
+61 7 3346 1852
Fax 15399 0
Email 15399 0
h.stallman@uq.edu.au
Contact person for scientific queries
Name 6327 0
Dr Helen Stallman
Address 6327 0
Schools of Medicine and Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
20 Cornwall Street
Woolloongabba, Qld 4102
Country 6327 0
Australia
Phone 6327 0
+61 7 3346 1852
Fax 6327 0
Email 6327 0
h.stallman@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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.