Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000449437
Ethics application status
Approved
Date submitted
24/08/2007
Date registered
31/08/2007
Date last updated
23/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
“Balance at Bond”: an Internet-Based Cognitive Behavioural Therapy program for reducing stress in Medical Students.
Scientific title
Forty first year medical students provided with access to an On-Line CBT program will be compared with forty students in a control group, to determine if there is a decrease in symptoms of stress, anxiety and depression following completion of the six modules.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
[Depression 2295 0
Anxiety 2296 0
Condition category
Condition code
Mental Health 2392 2392 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[“Balance at Bond”, a cognitive behavioural therapy program of six modules, with email support, will be made available on-line through the university web-site, to first year medical students who have been allocated a log in password. Completion of one module, through submission of an email, will result in the next module in the sequence being made available to be completed on-line. Modules include “relaxation strategies, thought stopping, disputing negative thoughts, challenging irrational thoughts and generating alternatives, problem solving and time management, activity and self reward strategies.”]It is anticipated that the intervention will require participants to read, reflect and complete an exercise for at least 30 minutes weekly, until all six modules have been completed.
Intervention code [1] 2009 0
Lifestyle
Intervention code [2] 2010 0
Prevention
Intervention code [3] 2011 0
Behaviour
Comparator / control treatment
compare those who receive "Balance at Bond" vs those who receive no intervention
Control group
Active

Outcomes
Primary outcome [1] 3292 0
Reduction in depression, anxiety and stress symptoms as measured on the DASS(depression, anxiety and stress scale)
Timepoint [1] 3292 0
Measures taken prior to and following completion of the on-line CBT intervention.
Secondary outcome [1] 5479 0
increase in stress management strategies
Timepoint [1] 5479 0
As measured through email feedback

Eligibility
Key inclusion criteria
Medical Students in first year of degree at a private university
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non-medical students, non-English speaking students

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)
A person not connected to the trial will distribute sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be created by random table from computer assigned software.
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
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 235 0
4229

Funding & Sponsors
Funding source category [1] 2550 0
Government body
Name [1] 2550 0
Primary Health Care Research Evaluation & Development
Country [1] 2550 0
Australia
Primary sponsor type
Government body
Name
Bond University
Address
PHCRED Qld
University of Queensland St
Brisbane
Country
Australia
Secondary sponsor category [1] 2309 0
University
Name [1] 2309 0
Bond University
Address [1] 2309 0
Faculty of Health Sciences and Medicine
Bond University
Gold Coast
Country [1] 2309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4476 0
Bond University Human Research Ethics Committee (BUHREC)
Ethics committee address [1] 4476 0
Ethics committee country [1] 4476 0
Australia
Date submitted for ethics approval [1] 4476 0
20/07/2007
Approval date [1] 4476 0
Ethics approval number [1] 4476 0
RO-645

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

Contacts
Principal investigator
Name 28005 0
Address 28005 0
Country 28005 0
Phone 28005 0
Fax 28005 0
Email 28005 0
Contact person for public queries
Name 11162 0
Sallie Gardner
Address 11162 0
PHCRED
Faculty of Health Sciences and Medicine
Bond University
Country 11162 0
Australia
Phone 11162 0
+61 7 5595 4493
Fax 11162 0
+61 7 5595 4122
Email 11162 0
sgardner@bond.edu.au
Contact person for scientific queries
Name 2090 0
Sallie Gardner
Address 2090 0
PHCRED
Bond University
Gold Coast
Country 2090 0
Australia
Phone 2090 0
+61 7 5595 4493
Fax 2090 0
+61 7 5595 4122
Email 2090 0
+61 7 5595 4122

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.