Evidence map›Paper›PMID 31779683›Full record

ArticleTrials2019

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.

Olga Sacristan-Martin, Miguel A Santed, Javier Garcia-Campayo, Larissa G Duncan, Nancy Bardacke, Carmen Fernandez-Alonso, Gloria Garcia-Sacristan, Diana Garcia-Sacristan, Alberto Barcelo-Soler, Jesus Montero-Marin

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03247491 (Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03247491 nacompletednot on this map

Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study

TypeinterventionalSponsorJavier Garcia CampayoRan2017 to 2019Enrolled122ConditionsPregnancy, Childbirth and PostpartumArmsMindfulness
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Compassion in Spanish-speaking health care: A systematic review.Current psychology (New Brunswick, N.J.) · 2023
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Olga Sacristan-MartinPrimary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain. olgasacristan@gmail.com.
Miguel A SantedDepartment of Personality Psychology, National University of Distance Education (UNED), Madrid, Spain.
Javier Garcia-CampayoAragon Institute for Health Research (Instituto de Investigacion Sanitaria Aragón (IIS Aragon), Miguel Servet Hospital, Psychiatry Service, University of Zaragoza, Zaragoza, Spain.
Larissa G DuncanCenter for Child & Family Well-Being, School of Human Ecology, University of Wisconsin-Madison, Madison, WI, USA.
Nancy BardackeMindful Birthing and Parenting Foundation, Oakland, CA, USA.
Carmen Fernandez-AlonsoPrimary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.
Gloria Garcia-SacristanPrimary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.
Diana Garcia-SacristanPrimary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.
Alberto Barcelo-SolerAragon Institute for Health Research (Instituto de Investigacion Sanitaria Aragón (IIS Aragon), Miguel Servet Hospital, Psychiatry Service, University of Zaragoza, Zaragoza, Spain.
Jesus Montero-MarinPrimary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.

Funding

Instituto de Investigación Sanitaria Aragón (IIS Aragón) G-99426132
6 · The paper itself

Abstract

backgroundPregnancy 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.

methodsA 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 registrationClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.

Indexed as

DepressionDepression, PostpartumEmpathyMindfulnessPregnancy ComplicationsFemaleHumansMaleMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicChildbirthCompassionMindfulnessPerinatal and postpartum depressionRCTStress in pregnancy

Identifiers

PMID31779683
PMCPMC6956498

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.