Target-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

Abstract

BackgroundDepression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months’ time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care.MethodsThe Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group.DiscussionTo our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR 12616000537459). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2089-y) contains supplementary material, which is available to authorized users.

Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care

“…The DST builds on a CPT developed for the Target-D RCT which predicts the severity of depressive symptoms at three months [15,16]. The Link-me DST has been adapted with advice from an Expert Advisory Panel to include the prediction of anxiety symptoms as well as depression, thereby capturing the majority of mental health presentations in the Australian population [17].…”

“…In this context, three PHNs have been selected to work with the University of Melbourne on Linkme, a randomised controlled trial (RCT) of a systematic approach to stepped mental health care. Link-me builds on over 15 years of research, including the development of a clinical prediction tool (CPT) from a ten year longitudinal cohort study of depression and preliminary testing of that tool in a systematic approach to identification of and tailored treatment for depression in the Target-D RCT [14][15][16]. Link-me uses a Decision Support Tool (DST) completed by patients in the general practice setting to predict the future severity of depressive and anxiety symptoms, and triage patients into high or low intensity care accordingly.…”

“…This process, in combination with the person-centred approach to recommending treatment as part of the DST, is designed to improve workflow and treatment engagement. It builds on evidence showing that simply alerting the GP to a patient's score on completion of a screening tool does not improve health outcomes [21,22], and our experience in the Target-D trial [15].…”

“… A self-report resource use questionnaire (RUQ), adapted from one used previously in Australian trials of mental health interventions [15,45,46]. The RUQ assesses the nature, frequency and duration of use of relevant health services (including low intensity services such as online programs and mobile phone apps) during the past 6 months, as well as the impact of mental health problems on productivity.…”

“…Based on our diamond [47] and Target-D [15] studies we assume that around 15% of participants will fall into the moderate symptom group and be excluded from the trial analyses. Of the remainder, 76.5% will be identified as belonging to the minimal/mild symptom group and a smaller proportion (23.5%) will fall into the severe symptom group.…”