Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications.

Autor: Melnyk BM; Health Promotion and Wellness, The Ohio State University, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, College of Nursing, Pediatrics & Psychiatry, College of Medicine, The Ohio State University, 1585 Neil Ave, Columbus, OH 43210, United States of America. Electronic address: melnyk.15@osu.edu., Gennaro S; William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America., Szalacha LA; Research Methodology and Biostatistics Core, USF Health Morsani College of Medicine, College of Nursing, University of South Florida, United States of America., Hoying J; Consumer Core, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, The Ohio State University College of Nursing, Columbus, OH, United States of America., O'Connor C; William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America., Cooper A; The Ohio State University College of Nursing, Columbus, OH, United States of America., Gibeau A; Midwifery, Jacobi Medical Center, Bronx, NY, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2020 Nov; Vol. 98, pp. 106090. Date of Electronic Publication: 2020 Jul 31.
DOI: 10.1016/j.cct.2020.106090
Abstrakt: Background: Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them.
Aim: Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms.
Methods: Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed.
Conclusion: If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.
(Copyright © 2020 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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