Feasibility and Preliminary Efficacy of Enhanced Midwifery Care to Support Women Experiencing Subclinical Depression: A Pilot Randomised Controlled Trial
Abstract
This study investigated the feasibility and preliminary effects of enhanced midwifery care in reducing subclinical depression symptoms among women in ethnically diverse areas of the South Western Sydney Local Health District (SWSLHD). A pilot randomised controlled trial was conducted among pregnant women attending the Fairfield and/or Liverpool antenatal clinic with an Edinburgh Depression Scale (EDS) score of 10-12 (i.e., just below the generally accepted clinical cut-off score of 13 to indicate subclinical depressive symptoms) during the first antenatal visit (i.e., before 26 weeks gestation). Participants were randomly allocated to either the intervention group which received continuous and coordinated support from a dedicated Registered Midwife (RM) trained in counselling and linked with a multidisciplinary team, or the usual care group, which received standard maternity care from various providers without continuity or additional coordinated support. Primary outcomes included feasibility of recruitment, randomisation, intervention delivery and fidelity, and retention and follow-up. The secondary outcomes were improvement in depressive symptom severity assessed via EDS, psychological distress (Kessler's psychological distress scale-K10), and parenting confidence (Karitane Parenting Confidence Scale (KPCS). Descriptive analyses were used to assess the feasibility outcomes, whereas mixed-effects models were used to examine the effects of treatment on secondary outcomes.…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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