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Trial registered on ANZCTR


Registration number
ACTRN12616000537459
Ethics application status
Approved
Date submitted
24/03/2016
Date registered
27/04/2016
Date last updated
26/03/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Target-D Study: An individually randomised controlled trial of a clinical prediction tool to triage and target treatment for depressive symptoms in general practice.
Scientific title
The Target-D Study: An individually randomised controlled trial of a clinical prediction tool to triage and target treatment for depressive symptoms in general practice.
Secondary ID [1] 286046 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294024 0
Condition category
Condition code
Mental Health 296283 296283 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises a systematic risk assessment, feedback and tailored treatment recommendation delivered using the Target-D Toolkit, which was developed by our team using findings from our naturalistic longitudinal cohort study of depression in Australian primary care (the diamond study). The Target-D Toolkit comprises 17 online multiple choice questions and takes about 2 minutes to complete. Patients will be invited to complete the toolkit in their GP waiting room, however GPs are not directly involved in toolkit completion. GPs will only become involved in Target-D where patients' toolkit responses indicate they are at high risk of chronic depression, In this case GPs will be informed of the patient's risk group and involved in the delivery of appropriate treatment (see details below).

Treatment recommendations are in line with current evidence on best practice for mild, moderate, and severe depression. Participants will complete the Target-D Toolkit on a purpose-built secure website and be triaged into low, medium, or high risk of chronic depression.

The low risk group will be offered self-help and automated follow-up using the myCompass internet based Cognitive Behavioural Therapy (iCBT) program which has been proven to be effective in reducing depressive symptoms and improving functioning in low risk individuals. myCompass is an interactive self-help internet resource consisting of information, accounts of others’ experiences, treatment modules with home tasks, and mood tracking functions. In line with standard myCompass recommendations, participants are encouraged to complete at least 2 modules over 8 weeks, but ultimately are free to use the myCompass program as much or as little as they like. Each module comprises three online lessons which take about 10-15 minutes. myCompass users are instructed to leave a week between each online lesson to complete home tasks and practice skills. myCompass encourages adherence with regular reminder texts and emails and collects information on the number of visits, modules completed, and moods tracked.

The medium risk group will be offered guided iCBT via the ThisWayUp program, which has been shown in several RCTs to be effective in reducing moderate symptoms of depression. ThisWayUp comprises six structured online lessons using CBT principles and includes lessons in the form of an illustrated story about someone with depression, printable summaries extra resources, and homework assignments, symptom monitoring, and vignettes written recovery stories by previous users about their own experiences. Lessons are completed in a linear order. Each lesson takes about 20 minutes to complete, and can be completed in one or multiple sittings. Each lesson is unlocked 5 days after the previous lesson has been completed, in order to allow time for patients to complete homework tasks. Participants are encouraged to complete the entire six-lesson course in 8 weeks. This Way Up patients receive weekly phone calls of approximately 10 minutes from a trained research assistant, providing support and encouragement to continue with the program. The system collects data on the frequency and duration of use and lessons completed.

The high risk group will be offered collaborative care, which is an enhanced form of patient care shown to be effective for treatment of moderate to severe depression in primary care. Key features of collaborative care include: provision of a trained case manager, who will develop a structured evidence based care plan with the participant; scheduled follow-ups and monitoring; and co-ordinated communication between health professionals involved in management. Patients will attend 8 sessions with their case manager over 12 weeks (weekly for the first 4 sessions and fortnightly thereafter). Case managers are qualified nurses. Other health professionals involved in care may involve mental health nurses, social workers, psychologists, or psychiatrists, as appropriate to the patient's needs. Patients will be referred to these professionals through normal processes. The evidence-based care plan meets the requirements of the Medicare mental health treatment plan, allowing subsidised access to mental health specialists through the Better Access program. It includes an assessment of patient history and current symptoms. It assists patients to identify their main concerns, and set goals in these areas. Nurses will provide psychoeducation and suggest appropriate treatments to patients as necessary. The nurse will provide a copy of the care plan to the patient's GP and discuss as appropriate. Patients will then see their GP for finalisation of the care plan and referrals and prescriptions where required. Ultimately, the GP retains responsibility for the patient's care and his or her role therefore is to review the care plan drafted by the patient and nurse and finalise as appropriate. Treatment adherence will be monitored by the nurse in the 7 follow-up appointments.
Intervention code [1] 292679 0
Treatment: Other
Intervention code [2] 292680 0
Early detection / Screening
Intervention code [3] 292681 0
Behaviour
Comparator / control treatment
Participants randomised to the usual care arm will be blinded to risk group allocation and will receive an attention control follow-up consultation from a trained research assistant. The research assistant will provide a structured consultation of approximatley 10-15 minutes, which uses a patient centred approach to identify participants’ perceptions of primary care research. Participants will also be informed that they will be asked for feedback on how they usually manage their emotional health and wellbeing. Neither they nor their GP will be informed of their risk status . They will be told that the study team will not be communicating with their GP about their care and that we will not inform the GP about their participation in the study. Participants will be aware that they are providing crucial information to help compare their experiences with those testing out a different approach. Participants will be encouraged to contact their GP if their condition worsens.

Upon commencement of the trial at each site, GPs will be instructed to continue to provide their normal depression care to all patients. This may include prescription of antidepressant medication, provision of supportive counselling or psychoeducation, or referral to mental health specialists. Detailed information about the nature of GPs' usual depression care will be collected through self-report surveys at commencement of the trial at each site in order to allow more specific description of this condition in reporting study results.
Control group
Active

Outcomes
Primary outcome [1] 295935 0
Depression symptom severity, assessed by the PHQ-9
Timepoint [1] 295935 0
3- and 12- months post randomisation
Secondary outcome [1] 316954 0
Cost efficacy, calculated by data linkage the Medicare Benefits Schedule and Pharmaceutical Benefits Scheme
Timepoint [1] 316954 0
3- and 12- months post randomisation
Secondary outcome [2] 322153 0
Quality of Life, assessed by the AQOL-12 (Richardson et al, 2014)
Timepoint [2] 322153 0
3- and 12- months post randomisation
Secondary outcome [3] 322154 0
Mental Health Self-Efficacy, assessed by the Mental Health Self-Efficacy Scale (Clarke et al, 2014)
Timepoint [3] 322154 0
3- and 12- months post randomisation
Secondary outcome [4] 322155 0
Generalised Anxiety, assessed using the GAD-7 (Spitzer et al, 2006)
Timepoint [4] 322155 0
3- and 12- months post randomisation

Eligibility
Key inclusion criteria
* Aged between 18 and 65 years old
* PHQ-2 score of 2 or more
* Regular access to a computer with internet
* Able to comply with study intervention and assessments (ie. sufficient English and reading skills)
* If taking antidepressant medication, at least 1 month with the same medication
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Currently taking antipsychotic medication
* Currently seeing or looking to see a psychologist in the next 3 months
* Currently accessing iCBT

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)
No one in the research team will know which group a participant will be allocated to at the time of enrolment in the study. Allocation to intervention arm will be concealed through central randomisation by an online algorithm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated sequentially within stratum using a biased-coin algorithm embedded within the study website, to assign individuals in a 1:1 ratio to intervention and UC arms
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to compare participant characteristics between the study arms overall and for each risk category and to assess for any imbalance. Analysis will be intention to treat. Linear regression will be used to compare the continuous outcome between study arms, with baseline outcome score and stratification (e.g. clinic) variables included as covariates. An interaction between study arm and risk category will be fitted in the model to estimate an intervention effect for each risk factor category. Logistic regression will be used for binary outcomes. Pre-specified baseline variables strongly associated with the outcome that are found to be imbalanced between the study arms will also be considered for adjustment in the regression analyses. If required, multiple imputation will be used to handle missing data assuming that data are missing at random. Sub-group analysis will be performed to determine whether the effect of the intervention was the same for each of the three risk/treatment groups

Sample size calculations are based upon our trial experience, a systematic review of depression trials, and current data from the diamond study. To test the study hypotheses, we require 158 (78 in each arm) participants in each of the moderate and severe groups to detect a standardized effect size of 0.5 and 740 (370 in each arm) in the mild/minimal group to detect a smaller standardized effect size of 0.2, with 80% power and 5% significance level for a two-sided test. This leads to an anticipated sample size of 1056 participants (528 in each arm). We inflated the required sample size to 1320 to allow for 20% attrition at 12 months.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
31/01/2018
Actual
10/01/2018
Date of last data collection
Anticipated
1/02/2019
Actual
15/02/2019
Sample size
Target
1056
Accrual to date
Final
1868
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291907 0
Government body
Name [1] 291907 0
National Health and Medical Research Council (NHRMC)
Country [1] 291907 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 291995 0
None
Name [1] 291995 0
Address [1] 291995 0
Country [1] 291995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293413 0
University of Melbourne Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 293413 0
Ethics committee country [1] 293413 0
Australia
Date submitted for ethics approval [1] 293413 0
27/04/2015
Approval date [1] 293413 0
15/06/2015
Ethics approval number [1] 293413 0
1543648

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

Contacts
Principal investigator
Name 51666 0
Prof Jane Gunn
Address 51666 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 51666 0
Australia
Phone 51666 0
+61 3 8344 4530
Fax 51666 0
Email 51666 0
j.gunn@unimelb.edu.au
Contact person for public queries
Name 51667 0
Amy Coe
Address 51667 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 51667 0
Australia
Phone 51667 0
+61 3 8344 3431
Fax 51667 0
Email 51667 0
amy.coe@unimelb.edu.au
Contact person for scientific queries
Name 51668 0
Susan Fletcher
Address 51668 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 51668 0
Australia
Phone 51668 0
+61 3 9035 4872
Fax 51668 0
Email 51668 0
susanlf@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from this trial will only be available to the research team


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1725Statistical analysis plan    367152-(Uploaded-26-03-2019-11-12-43)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTarget-D: A stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: Study protocol for a randomized controlled trial.2017https://dx.doi.org/10.1186/s13063-017-2089-y
EmbaseEconomic evaluation of the Target-D platform to match depression management to severity prognosis in primary care: A within-trial costutility analysis.2022https://dx.doi.org/10.1371/journal.pone.0268948
N.B. These documents automatically identified may not have been verified by the study sponsor.