Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding

Not Applicable

Completed

• Conditions: Pregnancy, Childbirth and Postpartum

• Registration Number: NCT03247491
• Lead Sponsor: Javier Garcia Campayo

Brief Summary

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. This group intervention will also be compared with a Treatment as usual (TAU) group consisting in a childbirth education class taught by the Health Center midwife. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU.

Detailed Description

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding.

There will be two groups:

1. A face to face mindfulness and compassion intervention for pregnant women in their second trimester of pregnancy and their partners in group format (8 weeks) based in the Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will also receive in their third trimester of pregnancy the childbirth education classes taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the National Health Care System in Spain (TAU).

2. A control group that will receive only the childbirth education class by midwives (TAU) group consisting in a childbirth education class taught by the Health Center midwife at the third trimester of pregnancy.

Each group will be composed of 60 participants with a total sample of 120. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU in the decrease of stress, negative affect and depression and in the increase of positive affect during pregnancy and breastfeeding.

The differences between the intervention and control group will be analyzed. Finally, a qualitative study will be conducted.

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-11
• Study Start: 2017-10-01
• Primary Completion: 2019-10-02
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

• Be at least 18 years old
• Willingness to participate in the study and signing informed consent
• Ability to understand and write Spanish.
• Women will be in their 6 to 25 weeks of pregnancy.
• All women eligible will be accepted with our without their partner.

Exclusion Criteria

• Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
• Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),
• Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
• Currently taking psychopharmacological medication or under psychopharmacological treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Edinburgh postnatal depression scale (EPDS)	Post-partum 6 months follow up in TAU control group

Secondary Outcome Measures

Name	Time	Method
Client service receipt inventory (CSRI)	Post-partum 6 months follow up in TAU control group
M.I.N.I. International Neuropsychiatric Interview	baseline applied in TAU and in intervention group	only if needed
Parental Evaluation Scale (EEP)	Post-partum 6 months follow up in TAU control group
Sociodemographic data Gender, age, marital status, education, occupation, economical level	Baseline	In the mindfulness-based intervention applied face-to-face and TAU control group
Medical data regarding delivery and breastfeeding	2 months after delivery	In the mindfulness-based intervention applied face-to-face and TAU control group
Positive and negative affect (PANAS)	Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)	Post-partum 6 months follow up in 8 weeks intervention group
Self Compassion Scale(SCS)	Post-partum 6 months follow up in TAU control group
Perceived Stress Scale (PSS)	Post-partum 6 weeks follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)	Post-partum 6 months follow up in TAU control group

Trial Locations

Locations (1)

Universidad Nacional de Educacion a Distancia; 🇪🇸 Valladolid, Spain