ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

Early detection / Screening

Intervention code [3]

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]

Depression symptom severity, assessed by the PHQ-9

Timepoint [1]