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.
Birth outcomes
Healthy lifestyle behaviors
Mental health
Minorities
Pregnant women
Randomized controlled trial
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
13
04
2020
revised:
14
07
2020
accepted:
20
07
2020
pubmed:
4
8
2020
medline:
25
9
2021
entrez:
4
8
2020
Statut:
ppublish
Résumé
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. 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. 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. If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.
Sections du résumé
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.
Identifiants
pubmed: 32745703
pii: S1551-7144(20)30168-3
doi: 10.1016/j.cct.2020.106090
pmc: PMC7686149
mid: NIHMS1632965
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106090Subventions
Organisme : NIMHD NIH HHS
ID : R01 MD012770
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
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