Trial Review

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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.
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
Secondary ID [1] 252951 0
nil
Universal Trial Number (UTN)
U1111-1117-5608
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 258483 0
Condition category
Condition code
Mental Health 258650 258650 0 0
Depression

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 257481 0
Treatment: Other
Intervention code [2] 264250 0
Behaviour
Comparator / control treatment
the control group will just be given the information sheet
Control group
Active

Outcomes
Primary outcome [1] 259501 0
PHQ-9 score and the Hopkins checklist for depression
Timepoint [1] 259501 0
4 months
Primary outcome [2] 262361 0
Hopkins depression checklist
Timepoint [2] 262361 0
4 months
Secondary outcome [1] 266090 0
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.
Timepoint [1] 266090 0
4 months

Eligibility
Key inclusion criteria
Uncomplicated depression
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
personality disorder
bipolar disorder
significant alcohol and drug condition
dementia
terminal illness

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)
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
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment outside Australia
Country [1] 2994 0
New Zealand
State/province [1] 2994 0

Funding & Sponsors
Funding source category [1] 257930 0
Charities/Societies/Foundations
Name [1] 257930 0
oakley mental health foundation
Country [1] 257930 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 257121 0
None
Name [1] 257121 0
Address [1] 257121 0
Country [1] 257121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259941 0
Northern Ethics Committee NTX/10/04/024
Ethics committee address [1] 259941 0
PO Box 92522
Wellesley Street
Auckland 1142
Ethics committee country [1] 259941 0
New Zealand
Date submitted for ethics approval [1] 259941 0
Approval date [1] 259941 0
03/06/2010
Ethics approval number [1] 259941 0
NTX/10/04/024

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

Contacts
Principal investigator
Name 31830 0
Address 31830 0
Country 31830 0
Phone 31830 0
Fax 31830 0
Email 31830 0
Contact person for public queries
Name 15077 0
Bruce Arroll
Address 15077 0
Dept of General Practice and Primary Health Care. University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 15077 0
New Zealand
Phone 15077 0
ph 64-9-9236978
Fax 15077 0
fax 64-9-3737624
Email 15077 0
email b.arroll@auckland.ac.nz
Contact person for scientific queries
Name 6005 0
Bruce Arroll
Address 6005 0
Dept of General Practice and Primary Health Care. University of Auckland
Private Bag 92019
Auckland
New Zealand
Country 6005 0
New Zealand
Phone 6005 0
ph 64-9-9236978
Fax 6005 0
fax 64-9-3737624
Email 6005 0
email b.arroll@auckland.ac.nz

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.