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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

Gunn, Jane, Wachtler, Caroline, Fletcher, Susan, Davidson, Sandra, Mihalopoulos, Cathrine, Palmer, Victoria, Hegarty, Kelsey, Coe, Amy, Murray, Elizabeth, Dowrick, Christopher, Andrews, Gavin and Chondros, Patty 2017, 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, Trials, vol. 18, pp. 1-14, doi: 10.1186/s13063-017-2089-y.

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Title 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
Author(s) Gunn, Jane
Wachtler, Caroline
Fletcher, Susan
Davidson, Sandra
Mihalopoulos, CathrineORCID iD for Mihalopoulos, Cathrine orcid.org/0000-0002-7127-9462
Palmer, Victoria
Hegarty, Kelsey
Coe, Amy
Murray, Elizabeth
Dowrick, Christopher
Andrews, Gavin
Chondros, Patty
Journal name Trials
Volume number 18
Article ID 342
Start page 1
End page 14
Total pages 14
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2017-07-20
ISSN 1745-6215
Keyword(s) Clinical prediction tool
Depression
General practice
Prognosis
Randomized controlled trial
Stepped care
Summary BACKGROUND: Depression 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.

METHODS: The 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.

DISCUSSION: To 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.
Language eng
DOI 10.1186/s13063-017-2089-y
Field of Research 111714 Mental Health
140208 Health Economics
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30099325

Document type: Journal Article
Collections: Faculty of Health
Population Health
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.