Selected article for: "analysis treat intention and trial design"

Author: Fletcher, Susan; Chondros, Patty; Densley, Konstancja; Murray, Elizabeth; Dowrick, Christopher; Coe, Amy; Hegarty, Kelsey; Davidson, Sandra; Wachtler, Caroline; Mihalopoulos, Cathrine; Lee, Yong Yi; Chatterton, Mary Lou; Palmer, Victoria J; Gunn, Jane
Title: Matching depression management to severity prognosis in primary care: results of the Target-D randomised controlled trial
  • Cord-id: hyipm590
  • Document date: 2021_1_12
  • ID: hyipm590
    Snippet: BACKGROUND: Mental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required. AIM: To investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care. DESIGN AND SETTING: Stratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 20
    Document: BACKGROUND: Mental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required. AIM: To investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care. DESIGN AND SETTING: Stratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18–65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care. METHOD: The intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months. RESULTS: In intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was −0.88 (95% confidence interval [CI] = −1.45 to −0.31) favouring the intervention, and −0.59 at 12 months (95% CI = −1.18 to 0.01); standardised effect sizes of −0.16 (95% CI = −0.26 to −0.05) and −0.10 (95% CI = −0.21 to 0.002), respectively. No serious adverse events were reported. CONCLUSION: Matching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options.

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