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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Childbirth and Postpartum
• Intervention / Treatment: Behavioral: Mindfulness

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47013
    • Universidad Nacional de Educación a Distancia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.	Behavioral: Mindfulness; TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
No Intervention: No intervention; Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh postnatal depression scale (EPDS)	In the mindfulness and compassion based intervention group	Baseline
Edinburgh postnatal depression scale (EPDS)	In the TAU control group	Baseline
Edinburgh postnatal depression scale (EPDS)		Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)		Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)		Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)		Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)		Post-partum 6 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)		Post-partum 6 months follow up in TAU control group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data Gender, age, marital status, education, occupation, economical level	In the mindfulness-based intervention applied face-to-face and TAU control group	Baseline
M.I.N.I. International Neuropsychiatric Interview	only if needed	baseline applied in TAU and in intervention group
Client service receipt inventory (CSRI)	In the mindfulness-based intervention applied face-to-face and TAU control group	Baseline
Client service receipt inventory (CSRI)		Post-partum 6 months follow up in 8 weeks intervention group
Client service receipt inventory (CSRI)		Post-partum 6 months follow up in TAU control group
Medical data regarding delivery and breastfeeding	In the mindfulness-based intervention applied face-to-face and TAU control group	2 months after delivery
Perceived Stress Scale (PSS)	In the mindfulness and compassion based intervention group	Baseline
Perceived Stress Scale (PSS)	In the TAU control group	Baseline
Perceived Stress Scale (PSS)		Post-treatment 8 weeks from baseline in 8 weeks intervention group
Perceived Stress Scale (PSS)		Post-treatment 8 weeks from baseline in TAU control group
Perceived Stress Scale (PSS)		Post-partum 3 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)		Post-partum 3 months follow up in TAU control group
Perceived Stress Scale (PSS)		Post-partum 6 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)		Post-partum 6 weeks follow up in TAU control group
Positive and negative affect (PANAS)	In the mindfulness and compassion based intervention group	Baseline
Positive and negative affect (PANAS)	In the TAU control group	Baseline
Positive and negative affect (PANAS)		Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)		Post-treatment 8 weeks from baseline in TAU control group
Positive and negative affect (PANAS)		Post-partum 3 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)		Post-partum 3 months follow up in TAU control group
Positive and negative affect (PANAS)		Post-partum 6 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)		Post-partum 6 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)	In the mindfulness and compassion based intervention group	Baseline
Five Facets and factors of mindfulness (FFMQ)	In the TAU control group	Baseline
Five Facets and factors of mindfulness (FFMQ)		Post-treatment 8 weeks from baseline in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)		Post-treatment 8 weeks from baseline in TAU control group
Five Facets and factors of mindfulness (FFMQ)		Post-partum 3 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)		Post-partum 3 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)		Post-partum 6 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)		Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)	In the mindfulness and compassion based intervention group	Baseline
Self Compassion Scale (SCS)	In the TAU control group	Baseline
Self Compassion Scale (SCS)	In the mindfulness and compassion based intervention group	Post-treatment 8 weeks from baseline in 8 weeks intervention group
Self Compassion Scale (SCS)		Post-treatment 8 weeks from baseline in TAU control group
Self Compassion Scale (SCS)		Post-partum 3 months follow up in 8 weeks intervention group
Self Compassion Scale (SCS)		Post-partum 3 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
Parental Evaluation Scale (EEP)		Post-partum 3 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)		Post-partum 3 months follow up in TAU control group
Parental Evaluation Scale (EEP)		Post-partum 6 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)		Post-partum 6 months follow up in TAU control group

Collaborators and Investigators

• Sponsor: Javier Garcia Campayo
• Collaborators: Universidad Nacional de Educación a Distancia

Publications and helpful links

General Publications

• Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
• Duncan, L.G., Cohn, M.A., Chao, M.T., Cook, J.G., Riccobono, J., & Bardacke, N. (2014a) Mind in labor: Effects of mind/body training on childbirth appraisals and pain medication use during labor. The Journal of Alternative and Complementary Medicine, 20, A17-A17.
• Duncan, L.G., Cohn, M.A., Cook, J.G., Hecht, F.M., & Bardacke, N. (2014b) The mind in labor: Employing mindfulness to alleviate fear and pain in childbirth. Poster presented at the 2nd biennial International Symposium for Contemplative Studies. Boston, MA.
• Duncan LG, Shaddix C. Mindfulness-Based Childbirth and Parenting (MBCP): Innovation in Birth Preparation to Support Healthy, Happy Families. Int J Birth Parent Educ. 2015 Jan;2(2):30-33. No abstract available.
• Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
• Sacristan-Martin O, Santed MA, Garcia-Campayo J, Duncan LG, Bardacke N, Fernandez-Alonso C, Garcia-Sacristan G, Garcia-Sacristan D, Barcelo-Soler A, Montero-Marin J. 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. 2019 Nov 28;20(1):654. doi: 10.1186/s13063-019-3739-z.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 2, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 1, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Stress; Mindfulness; Prevention; Compassion; Depression during Pregnancy and Postpartum
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 50/2014/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No