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Trial registered on ANZCTR
Registration number
ACTRN12613000402741
Ethics application status
Approved
Date submitted
2/04/2013
Date registered
12/04/2013
Date last updated
4/05/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Cluster randomised controlled trial of a psycho-educational intervention for people with a family history of depression for use in general practice
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Scientific title
A cluster randomised controlled trial comparing the efficacy of a targeted psycho-education intervention about depression to usual care in people with a family history of depression. The LINKS study.
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Secondary ID [1]
282202
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Nil
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Universal Trial Number (UTN)
U1111-1141-3281
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Trial acronym
LINKS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Family history of depression
288721
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Condition category
Condition code
Human Genetics and Inherited Disorders
289073
289073
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0
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Other human genetics and inherited disorders
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Mental Health
289074
289074
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0
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Depression
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Public Health
289139
289139
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be directed to an intervention group website by GPs. The intervention will incorporate:
a) a risk assessment - a 12-item survey to assess a participant's family history of mental illness;
b) risk-specific online education tailored to people with a family history of depression; and
c) sending feedback to general practitioners (GPs) of individuals’ risk status.
Participants will have secure login access to the website over the period of the study (6 months) and use will be monitored. They will be advised to read through all the information that they think is relevant the first time they access the website prior to completing the questionnaire. After this, they can access the website at their own discretion.
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Intervention code [1]
286816
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Lifestyle
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Intervention code [2]
286879
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Early detection / Screening
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Comparator / control treatment
Participants will be directed to a control group website by GPs. The control/ usual care arm will receive brief information about depression produced by beyondblue (National Depression Network), ‘Understanding depression’ on a website.
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Control group
Active
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Outcomes
Primary outcome [1]
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Intention to adopt risk-reducing strategies will be assessed via an online survey adapted from a measure used previously regarding attitudes to genetic testing to assess intention to adopt a range of risk-reducing strategies (e.g. screening regularly for depression symptoms; taking up psychological interventions; getting adequate exercise; reducing excessive drug or alcohol use; ensuring enough sleep; modifying/avoiding potential stressors, such as stressful job, relationship or domestic situation; and deciding not to have children).
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Assessment method [1]
289191
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Timepoint [1]
289191
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Immediately after working through the appropriate educational resource and at 6 months follow-up
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Secondary outcome [1]
301999
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Personal Health Questionnaire Depression Module (PHQ9-DM) - The PHQ9-DM is a self-administered validated instrument, which scores each of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD. It can be used both as a diagnostic measure as well as a symptom severity measure and assesses depression symptoms over the past two weeks
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Assessment method [1]
301999
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Timepoint [1]
301999
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Immediately after working through the appropriate educational resource and at 6 month follow-up.
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Secondary outcome [2]
302000
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Perceived Devaluation-Discrimination - This 12-item scale will be used to assess perceived stigma of depression. It assesses people’s perceptions of what ‘most other people’ believe regarding the stigma associated with depression, a key feature of modified labelling theory.
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Assessment method [2]
302000
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Timepoint [2]
302000
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Immediately after working through the appropriate educational resource and at 6 month follow-up.
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Secondary outcome [3]
302001
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Acceptability of the information materials - : This will be assessed by asking participants to rate relevance of the information and other measures of comprehensibility.
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Assessment method [3]
302001
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Timepoint [3]
302001
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Immediately after working through the appropriate educational resource.
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Secondary outcome [4]
302002
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Knowledge of risk factors for development of depression and risk-reducing strategies - Approx. 10 items will be designed to assess knowledge of genetic and non-genetic risk factors.
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Assessment method [4]
302002
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Timepoint [4]
302002
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Immediately after working through the appropriate educational resource and at 6 month follow-up.
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Secondary outcome [5]
302003
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Accuracy of perceived risk imparted by different degrees of family history - Two items will be developed to assess accuracy of understanding of empiric recurrence risks according to the participant’s personal and family history of depression.
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Assessment method [5]
302003
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Timepoint [5]
302003
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Immediately after working through the appropriate educational resource and at 6 month follow-up.
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Secondary outcome [6]
302004
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Adoption of risk-reducing strategies - These items will assess actual uptake of a range of risk-reducing strategies and will be analogous to those assessing intention (primary outcome). This will be adapted from a measure used previously regarding attitudes to genetic testing to assess intention to adopt a range of risk-reducing strategies (e.g. screening regularly for depression symptoms; taking up psychological interventions; getting adequate exercise; reducing excessive drug or alcohol use; ensuring enough sleep; modifying/avoiding potential stressors, such as stressful job, relationship or domestic situation; and deciding not to have children)
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Assessment method [6]
302004
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Timepoint [6]
302004
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Immediately after working through the appropriate educational resource and at 6 month follow-up.
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Eligibility
Key inclusion criteria
The research sample will include people with a family history presenting to their GP who:
(i) are able to give informed consent;
(ii) are proficient readers in English; and
(iii) are aged 18 years and over;
(iv) have at least one 1st degree relative diagnosed with depression.
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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?
Yes
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Key exclusion criteria
N/A
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Study design
Purpose of the study
Educational / counselling / training
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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)
Metropolitan and rural GPs in NSW and Victoria will be broadly sampled, sourced through SydReN (Sydney Research Network) and VicReN (Victorian Research Network). Upon agreeing to participate in the study, researchers will work with staff at GP practices to generate random lists of patients from the patients attending these GP practices that satisfy the following criteria:
(i) are able to give informed consent;
(ii) are proficient readers in English; and
(iii) are aged 18 years and over;
Potential participants will be sent a letter inviting them to participate in the study, As many GPs do not elicit and record systematically a family history of depression, patients will be asked to self-identify as having a 1st degree relative with depression. Should patient’s satisfy the forth eligibility criterion they will have the option to opt into the study and informed consent will be obtained from interested indivuduals.
Cluster randomisation by participating GP will be undertaken centrally using a computer-based randomisation program, and 20 GPs will be randomised to each arm.
Potential participants will be blinded to their intervention assignment in that they will be told that the study is comparing different types of educational interventions. The letter will direct interested individuals to the appropriate study website according to GP randomisation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-based randomisation program will be used.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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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
Analysis for the dichotomous primary outcome, intention to adopt risk-reducing strategies, will be performed using the generalised linear mixed model, which extends the standard logistic regression model to allow for clustered data. The continuous outcome of PHQ9-DM will be analysed using the linear mixed model. Adjustment for any potential confounding variables (such as age, sex, type of family history) will be made if there is important baseline imbalance in these variables between intervention groups.
We know from our previous work that approximately 25% of patients will opt-in to an online trial following an invitation letter from their GP. Based on as yet unpublished data from the 2010 National Survey of Mental Health and Wellbeing, at least 20% of Australian residents have at least one 1st degree relative with either MDD or BPD. Based on these figures, it is estimated that approximately 8,000 (200 per practice) who meet the eligibility criteria (i) to (iii) above will need to be sent invitation letters, to achieve the target sample size. Allowing for an attrition rate of 10% at the 6 month follow up, it is expected that 180 completed sets of questionnaires each will have been completed by individuals in the intervention and control groups. All calculations assume an intracluster correlation coefficient of 0.06, consistent with ICCs observed for psychological problems in patient encounters in Australian general practice.
The primary outcome measure will be ‘Intention to adopt risk-reducing strategies’; on the basis of our quantitative survey of a large nationally representative population sample of 1046 Australian participants, we expect a mean baseline percentage of 50% of people intending to adopt a range of risk-reducing strategies. We opted for behavioural intentions as our primary outcome variable to gain an understanding of the issues related to this topic and while behavioural intentions are only an indirect measure of actual practice, at present they are the best single predictor of future behaviour in the psychological literature. Taking into account clustering within GP, where the cluster size=9 and the intraclass correlation coefficient (ICC) is 0.06 (for patients attending the same GP), a sample size of 180 in each group will detect a difference of 18% or more between intervention and control groups at a 0.05 level of significance with 80% power.
This sample size will also detect a difference of two scores on the PHQ9-DM (based on a SD=6.1, range 0 to 27, corresponding to an effect size difference of 0.4) between the intervention and control group. This difference is based on the smallest effect that would have clear public health significance and provides a sensitive indicator of clinically meaningful differences.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2014
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Actual
18/11/2015
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Date of last participant enrolment
Anticipated
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Actual
9/09/2016
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Date of last data collection
Anticipated
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Actual
23/09/2016
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Sample size
Target
240
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Accrual to date
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Final
202
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
286988
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Government body
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Name [1]
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Australian Research Council (ARC)
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Address [1]
286988
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Level 2, 11 Lancaster Place
Majura Park ACT 2609
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Country [1]
286988
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
Anzac Parade,
The University of New South Wales
SYDNEY NSW 2052
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Country
Australia
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Secondary sponsor category [1]
285775
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None
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Name [1]
285775
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Address [1]
285775
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Country [1]
285775
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289038
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University of New South Wales (UNSW) Human Research Ethics Committee (HREC)
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Ethics committee address [1]
289038
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Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
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Ethics committee country [1]
289038
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Australia
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Date submitted for ethics approval [1]
289038
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28/06/2013
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Approval date [1]
289038
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06/02/2014
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Ethics approval number [1]
289038
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Summary
Brief summary
The strongest risk factor for depression is having a family history of the condition. Many individuals with a family history of depression are concerned about their personal risk for depression. In this study we will develop and evaluate the first online psycho-educational intervention nationally and internationally targeted to individuals with a family history of depression. An intervention incorporating a risk assessment tool and delivery of education tailored to people with a family history of depression will be developed and pilot tested. The intervention will be delivered by general practitioners (GPs) and evaluated using a cluster randomised controlled trial (RCT) methodology.
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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
38810
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A/Prof Bettina Meiser
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Address
38810
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Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
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Country
38810
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Australia
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Phone
38810
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+61, 02, 93822638
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Fax
38810
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+61,02,93823372
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Email
38810
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[email protected]
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Contact person for public queries
Name
38811
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A/Prof Bettina Meiser
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Address
38811
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Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
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Country
38811
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Australia
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Phone
38811
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+61, 02, 93822638
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Fax
38811
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+61,02,93823372
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Email
38811
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[email protected]
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Contact person for scientific queries
Name
38812
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A/Prof Bettina Meiser
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Address
38812
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Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
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Country
38812
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Australia
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Phone
38812
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+61, 02, 93822638
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Fax
38812
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+61,02,93823372
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Email
38812
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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
A cluster randomized controlled trial of an online psychoeducational intervention for people with a family history of depression.
2019
https://dx.doi.org/10.1186/s12888-018-1994-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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