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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
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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?
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Secondary ID [1]
262956
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0931313
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
252144
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
241369
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Prevention
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Intervention code [2]
241370
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Treatment: Other
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-9, self-rated)
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Assessment method [1]
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Timepoint [1]
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Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
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Primary outcome [2]
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Reduction in development of major depression, as assessed using the PHQ-9 (self-rated).
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Assessment method [2]
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Timepoint [2]
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Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
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Secondary outcome [1]
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Change in psychological distress as assessed using the K10 (self-rated)
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Assessment method [1]
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Timepoint [1]
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Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
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Secondary outcome [2]
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Change in functioning as assessed using the Work and Social Adjustment Scale (self-rated)
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Assessment method [2]
257821
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Timepoint [2]
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Baseline, intervention mid-point (3 weeks), post-intervention (6 weeks), 6 months post-intervention
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Secondary outcome [3]
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Change in coping strategies used (researcher devised questionaire)
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Assessment method [3]
257822
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Timepoint [3]
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Baseline and post-intervention (6 weeks)
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Secondary outcome [4]
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Change in knowledge of depression (researcher devised questionnaire)
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Assessment method [4]
257823
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Timepoint [4]
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Baseline and post-intervention (6 weeks)
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Currently receiving treatment for depression from a professional
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2010
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Actual
14/02/2010
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Date of last participant enrolment
Anticipated
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Actual
31/03/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1200
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Accrual to date
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Final
1326
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
2215
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New Zealand
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State/province [1]
2215
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Country [2]
2216
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Canada
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State/province [2]
2216
0
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Country [3]
2217
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Ireland
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State/province [3]
2217
0
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Country [4]
2218
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United States of America
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State/province [4]
2218
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Country [5]
2219
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United Kingdom
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State/province [5]
2219
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Funding & Sponsors
Funding source category [1]
243831
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Funding source category [2]
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University
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Name [2]
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University of Melbourne
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Address [2]
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Centre for Youth Mental Health
Locked Bag 10
Parkville VIC 3052
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Country [2]
243832
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Australia
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Funding source category [3]
243833
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Charities/Societies/Foundations
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Name [3]
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Sidney Myer Fund
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Address [3]
243833
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Level 18
8 Exhibition Street
Melbourne, Victoria 3000
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Country [3]
243833
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
Centre for Youth Mental Health
Locked Bag 10
Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
237179
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Country [1]
237179
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Melbourne Health Sciences Human Ethics Sub-Committee
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Ethics committee address [1]
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Melbourne Research Office University of Melbourne Victoria 3010
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
243960
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Approval date [1]
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04/06/2009
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Ethics approval number [1]
243960
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0931313
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Summary
Brief summary
This project will test the effectiveness and feasibility of promoting helpful self-help strategies to individuals with depressive symptoms (but not major depression) via regular emails. The effect of these will be compared to receiving emails containing general information about depression. We wish to see whether the emails reduce depressive symptoms in participants, and whether they prevent participants from developing major depression.
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Trial website
www.moodmemos.com
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Trial related presentations / publications
Morgan, A. J., et al. (2013). "Internet-based recruitment to a depression prevention intervention: Lessons from the Mood Memos study." Journal of Medical Internet Research 15(2): e31. Morgan, A. J., et al. (2012). "Email-based promotion of self-help for sub-threshold depression: The Mood Memos randomised controlled trial." British Journal of Psychiatry 200: 412-418. Morgan, A. J., et al. (2012). "Usage and reported helpfulness of self-help strategies by adults with sub-threshold depression." Journal of Affective Disorders 136: 393-397. Morgan, A. J., et al. (2013). "Behavior change through automated e-mails: Mediation analysis of self-help strategy use for depressive symptoms." Behaviour Research and Therapy 51: 57-62.
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Public notes
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Contacts
Principal investigator
Name
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Dr Amy Morgan
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Address
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Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
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Country
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Australia
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Phone
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+61 3 9479 5193
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Amy Morgan
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Address
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Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
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Country
13600
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Australia
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Phone
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+61 3 9479 5193
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Fax
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+61 3 9479 1956
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Email
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[email protected]
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Contact person for scientific queries
Name
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Amy Morgan
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Address
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Melbourne School of Population and Global Health
The University of Melbourne
207 Bouverie Street
Parkville Victoria 3010
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Country
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Australia
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Phone
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+61 3 9479 5193
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Fax
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+61 3 9479 1956
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Protocol for a randomised controlled trial investigating self-help email messages for sub-threshold depression: The Mood Memos study.
2011
https://dx.doi.org/10.1186/1745-6215-12-11
N.B. These documents automatically identified may not have been verified by the study sponsor.
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