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Trial registered on ANZCTR
Registration number
ACTRN12611000299909
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
21/03/2011
Date last updated
21/03/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Randomised trial of gratitude diaries for depressed patients using office based internet software.
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Scientific title
In primary care patients who are depressed with a PHQ score >9 does giving a gratitude diary in addition to an information sheet on depression result in lower PHQ scores after 4 months
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Secondary ID [1]
252951
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nil
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Universal Trial Number (UTN)
U1111-1117-5608
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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
258483
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Condition category
Condition code
Mental Health
258650
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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
The intervention group will be given a gratitude diary and an information sheet about depression. A gratitude diary is a book in which one is instructed to write down three things each day that they are grateful for and what they have done to cause that. This is done for one week then just once per week thereafter. The underlying theory is that it changes an individuals focus from what is not working to what is working. The duration of the study is four months
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Intervention code [1]
257481
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Treatment: Other
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Intervention code [2]
264250
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Behaviour
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Comparator / control treatment
the control group will just be given the information sheet
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Control group
Active
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Outcomes
Primary outcome [1]
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PHQ-9 score and the Hopkins checklist for depression
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Assessment method [1]
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Timepoint [1]
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4 months
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Primary outcome [2]
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Hopkins depression checklist
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Assessment method [2]
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Timepoint [2]
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4 months
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Secondary outcome [1]
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GAD- the GAD is an anxiety inventory which can be used to diagnose generalised anxiety disorder, panic disorder, post traumatic stress disorder and social anxiety disorder.
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Assessment method [1]
266090
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Timepoint [1]
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4 months
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Eligibility
Key inclusion criteria
Uncomplicated depression
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Minimum age
16
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
personality disorder
bipolar disorder
significant alcohol and drug condition
dementia
terminal illness
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Study design
Purpose of the study
Treatment
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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)
We are using OfficeRCT software specifically developed for this trial. Once enrolled a message is sent to an offsite server which allocates either intervention or control on a random basis
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We are using OfficeRCT software specifically developed for this trial. Once enrolled a message is sent to an offsite server which allocates either intervention or control on a random basis
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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
Patients will be told there are two interventions and they will only be told of the one they are getting. At the end of the study they will be told of the other arm
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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
Recruiting
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Date of first participant enrolment
Anticipated
26/10/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
196
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2994
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New Zealand
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State/province [1]
2994
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Funding & Sponsors
Funding source category [1]
257930
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Charities/Societies/Foundations
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Name [1]
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oakley mental health foundation
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Address [1]
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Box 36-271
Northcote Auckland0748
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Private Bag 92019
Auckland 1142
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Country
New Zealand
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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]
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Country [1]
257121
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Ethics Committee NTX/10/04/024
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Ethics committee address [1]
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PO Box 92522
Wellesley Street
Auckland 1142
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
259941
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Approval date [1]
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03/06/2010
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Ethics approval number [1]
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NTX/10/04/024
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Bruce Arroll
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Address
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Dept of General Practice and Primary Health Care. University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
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Country
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New Zealand
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Phone
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ph 64-9-9236978
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Fax
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fax 64-9-3737624
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Email
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email
[email protected]
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Contact person for scientific queries
Name
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Bruce Arroll
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Address
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Dept of General Practice and Primary Health Care. University of Auckland
Private Bag 92019
Auckland
New Zealand
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Country
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New Zealand
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Phone
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ph 64-9-9236978
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Fax
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fax 64-9-3737624
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Email
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email
[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
No additional documents have been identified.
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