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A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial.

Trials
January 1, 1970
Olga Sacristan-Martin et al. (10 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to assess the efficacy of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program, including compassion training, in reducing perinatal depression among pregnant women in Spanish primary care settings.

Results Summary

The study proposes to evaluate the program's impact on depression (measured by EPDS) and secondary outcomes like stress, mindfulness, and self-compassion, but results are not yet reported as it is a planned RCT.

Population

Pregnant women (n=122) and their partners in Spanish primary care settings.

Effective Dosage

Not specified

Duration

Assessments at baseline, post-treatment, and at three and six months after childbirth (exact intervention duration not specified).

Interactions

None mentioned

Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Mindfulness and compassion-based educational programs
decrease
perinatal mood disorders
women in the perinatal period
-
could be efficacious and cost-effective options
#1
adapted Mindfulness-Based Childbirth and Parenting (MBCP) program that includes compassion training
decrease
perinatal depression
pregnant women in primary care (PC) settings in the Spanish National Health System
-
to decrease
#2
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
depression
pregnant women (n = 122) and their partners
-
will be assessed
#3
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
perceived stress
pregnant women (n = 122) and their partners
-
will be assessed
#4
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
affects
pregnant women (n = 122) and their partners
-
will be assessed
#5
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
mindfulness
pregnant women (n = 122) and their partners
-
will be assessed
#6
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
self-compassion
pregnant women (n = 122) and their partners
-
will be assessed
#7
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
maternal self-efficacy
pregnant women (n = 122) and their partners
-
will be assessed
#8
adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU)
neutral
use of health and social services
pregnant women (n = 122) and their partners
-
will be assessed
#9
childbirth education program that incorporates mindfulness and compassion practices
decrease
perinatal depression
expectant women and their partners
-
may be a beneficial preventive complementary healthcare modality
#10
adapted MBCP and compassion practices
decrease
symptoms of depression
women during pregnancy and the postpartum period
-
to reduce
#11
Abstract

BACKGROUND: Pregnancy and the postpartum period are times of great change for women and their partners, often bringing substantial challenges and stress. Approximately 10%-20% of women suffer from mood disorders such as depression in the perinatal period. There are risks involved in using psychopharmacological interventions to treat perinatal depression. Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders. The aim of this study is to assess the efficacy of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program that includes compassion training for pregnant women in primary care (PC) settings in the Spanish National Health System to decrease perinatal depression. METHODS: A multicenter randomized controlled trial (RCT) will be conducted. Participants will be pregnant women (n = 122) and their partners who wish to participate. They will be enrolled and assessed in PC settings and randomly assigned to either: (1) an adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU); or (2) TAU only. The main outcome to be assessed will be depression, evaluated with the Edinburgh Postnatal Depression Scale (EPDS). Secondary outcomes will include self-reported measures of perceived stress, affects, mindfulness, self-compassion, maternal self-efficacy, and use of health and social services. Patients will be assessed at four timepoints: baseline; post-treatment; and at three and six months after childbirth. Intention-to-treat and per-protocol analyses will be carried out using linear regression mixed models. Effect sizes will be estimated using Cohen's d. DISCUSSION: Perinatal depression is a significant health problem. An effective and low-cost childbirth education program that incorporates mindfulness and compassion practices may be a beneficial preventive complementary healthcare modality for expectant women and their partners. This study will be the first multicenter RCT in Spanish PC settings using adapted MBCP and compassion practices to reduce symptoms of depression during pregnancy and the postpartum period. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.

Medical Subject Headings (MeSH)
FemaleHumansMalePregnancyDepressionDepression, PostpartumEmpathyMindfulnessPregnancy ComplicationsRandomized Controlled Trials as TopicMulticenter Studies as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations11
Citations/Year1.8
Relative Citation Ratio1.12
NIH Percentile54.5%
Research Impact Scores
APT Score0.50
Weight Score1.73
Normalized Score0.67
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