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Trial registered on ANZCTR


Registration number
ACTRN12609000925246
Ethics application status
Approved
Date submitted
26/10/2009
Date registered
28/10/2009
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Promotion of self-help strategies for sub-threshold depression: An e-mental health randomised controlled trial
Scientific title
For adult internet users with sub-threshold depression, is receiving email messages promoting self-help strategies more effective than receiving email messages with general information about depression, for reducing depressive symptoms and preventing major depression?
Secondary ID [1] 262956 0
0931313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 251958 0
Condition category
Condition code
Mental Health 252144 252144 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 12 emails over 6 weeks. Each email will contain a self-help strategy for coping with depressive symptoms. The email will contain information about why the strategy will be effective, tips for implementing the strategy and overcoming barriers, and how to set a goal to implement the strategy. Strategies are based on previous research published by the trial co-ordinators.
Intervention code [1] 241369 0
Prevention
Intervention code [2] 241370 0
Treatment: Other
Comparator / control treatment
Participants will receive 12 emails over 6 weeks. Each email will contain different information about depression, such as symptoms, risk factors, prevalence, history.
Control group
Placebo

Outcomes
Primary outcome [1] 253017 0
Change in depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-9, self-rated)
Timepoint [1] 253017 0
Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
Primary outcome [2] 253018 0
Reduction in development of major depression, as assessed using the PHQ-9 (self-rated).
Timepoint [2] 253018 0
Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
Secondary outcome [1] 257820 0
Change in psychological distress as assessed using the K10 (self-rated)
Timepoint [1] 257820 0
Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
Secondary outcome [2] 257821 0
Change in functioning as assessed using the Work and Social Adjustment Scale (self-rated)
Timepoint [2] 257821 0
Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
Secondary outcome [3] 257822 0
Change in coping strategies used (researcher devised questionaire)
Timepoint [3] 257822 0
Baseline and post-intervention (6 weeks)
Secondary outcome [4] 257823 0
Change in knowledge of depression (researcher devised questionnaire)
Timepoint [4] 257823 0
Baseline and post-intervention (6 weeks)

Eligibility
Key inclusion criteria
1) Resident of Australia, New Zealand, UK, Ireland, Canada or the USA
2) Access to the Internet at least weekly
3) Sub-threshold symptoms of depression (two to four symptoms of depression, experienced for two or more weeks, that have affected work, home, or social functioning)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Currently receiving treatment for depression from a professional

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
14/02/2010
Date of last participant enrolment
Anticipated
Actual
31/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
1326
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2215 0
New Zealand
State/province [1] 2215 0
Country [2] 2216 0
Canada
State/province [2] 2216 0
Country [3] 2217 0
Ireland
State/province [3] 2217 0
Country [4] 2218 0
United States of America
State/province [4] 2218 0
Country [5] 2219 0
United Kingdom
State/province [5] 2219 0

Funding & Sponsors
Funding source category [1] 243831 0
Government body
Name [1] 243831 0
National Health and Medical Research Council
Country [1] 243831 0
Australia
Funding source category [2] 243832 0
University
Name [2] 243832 0
University of Melbourne
Country [2] 243832 0
Australia
Funding source category [3] 243833 0
Charities/Societies/Foundations
Name [3] 243833 0
Sidney Myer Fund
Country [3] 243833 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Youth Mental Health
Locked Bag 10
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 237179 0
None
Name [1] 237179 0
Address [1] 237179 0
Country [1] 237179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243960 0
University of Melbourne Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 243960 0
Ethics committee country [1] 243960 0
Australia
Date submitted for ethics approval [1] 243960 0
Approval date [1] 243960 0
04/06/2009
Ethics approval number [1] 243960 0
0931313

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

Contacts
Principal investigator
Name 30353 0
Dr Amy Morgan
Address 30353 0
Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
Country 30353 0
Australia
Phone 30353 0
+61 3 9479 5193
Fax 30353 0
Email 30353 0
ajmorgan@unimelb.edu.au
Contact person for public queries
Name 13600 0
Amy Morgan
Address 13600 0
Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
Country 13600 0
Australia
Phone 13600 0
+61 3 9479 5193
Fax 13600 0
+61 3 9479 1956
Email 13600 0
ajmorgan@unimelb.edu.au
Contact person for scientific queries
Name 4528 0
Amy Morgan
Address 4528 0
Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
Country 4528 0
Australia
Phone 4528 0
+61 3 9479 5193
Fax 4528 0
+61 3 9479 1956
Email 4528 0
ajmorgan@unimelb.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
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised controlled trial investigating self-help email messages for sub-threshold depression: The Mood Memos study.2011https://dx.doi.org/10.1186/1745-6215-12-11
N.B. These documents automatically identified may not have been verified by the study sponsor.