Trial Review

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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
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.
Secondary ID [1] 282202 0
Nil
Universal Trial Number (UTN)
U1111-1141-3281
Trial acronym
LINKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family history of depression 288721 0
Condition category
Condition code
Human Genetics and Inherited Disorders 289073 289073 0 0
Other human genetics and inherited disorders
Mental Health 289074 289074 0 0
Depression
Public Health 289139 289139 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286816 0
Lifestyle
Intervention code [2] 286879 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 289191 0
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).
Timepoint [1] 289191 0
Immediately after working through the appropriate educational resource and at 6 months follow-up
Secondary outcome [1] 301999 0
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
Timepoint [1] 301999 0
Immediately after working through the appropriate educational resource and at 6 month follow-up.
Secondary outcome [2] 302000 0
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.
Timepoint [2] 302000 0
Immediately after working through the appropriate educational resource and at 6 month follow-up.
Secondary outcome [3] 302001 0
Acceptability of the information materials - : This will be assessed by asking participants to rate relevance of the information and other measures of comprehensibility.
Timepoint [3] 302001 0
Immediately after working through the appropriate educational resource.
Secondary outcome [4] 302002 0
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.
Timepoint [4] 302002 0
Immediately after working through the appropriate educational resource and at 6 month follow-up.
Secondary outcome [5] 302003 0
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.
Timepoint [5] 302003 0
Immediately after working through the appropriate educational resource and at 6 month follow-up.
Secondary outcome [6] 302004 0
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)
Timepoint [6] 302004 0
Immediately after working through the appropriate educational resource and at 6 month follow-up.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-based randomisation program will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
18/11/2015
Date of last participant enrolment
Anticipated
Actual
9/09/2016
Date of last data collection
Anticipated
Actual
23/09/2016
Sample size
Target
240
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286988 0
Government body
Name [1] 286988 0
Australian Research Council (ARC)
Country [1] 286988 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Anzac Parade,
The University of New South Wales
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 285775 0
None
Name [1] 285775 0
Address [1] 285775 0
Country [1] 285775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289038 0
University of New South Wales (UNSW) Human Research Ethics Committee (HREC)
Ethics committee address [1] 289038 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 289038 0
Australia
Date submitted for ethics approval [1] 289038 0
28/06/2013
Approval date [1] 289038 0
06/02/2014
Ethics approval number [1] 289038 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38810 0
A/Prof Bettina Meiser
Address 38810 0
Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
Country 38810 0
Australia
Phone 38810 0
+61, 02, 93822638
Fax 38810 0
+61,02,93823372
Email 38810 0
b.meiser@unsw.edu.au
Contact person for public queries
Name 38811 0
A/Prof Bettina Meiser
Address 38811 0
Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
Country 38811 0
Australia
Phone 38811 0
+61, 02, 93822638
Fax 38811 0
+61,02,93823372
Email 38811 0
b.meiser@unsw.edu.au
Contact person for scientific queries
Name 38812 0
A/Prof Bettina Meiser
Address 38812 0
Psychosocial Research Group
Prince of Wales Clinical School UNSW
Prince of Wales Hospital
Dickinson Bldg Level 3
Barker St, Randwick NSW 2031
Country 38812 0
Australia
Phone 38812 0
+61, 02, 93822638
Fax 38812 0
+61,02,93823372
Email 38812 0
b.meiser@unsw.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
EmbaseA cluster randomized controlled trial of an online psychoeducational intervention for people with a family history of depression.2019https://dx.doi.org/10.1186/s12888-018-1994-2
N.B. These documents automatically identified may not have been verified by the study sponsor.