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CompletedNCT03247491Updated Dec 3, 2019

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

An interventional study of Mindfulness in Pregnancy, Childbirth and Postpartum, sponsored by Javier Garcia Campayo. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by Javier Garcia Campayo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy, Childbirth and Postpartum

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Keywords

  • Mindfulness
  • Compassion
  • Depression during Pregnancy and Postpartum
  • Prevention
  • Stress
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 122 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Javier Garcia Campayo is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • 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

  • 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).

Interventions

  • BehavioralMindfulness

    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.

06

What researchers measure

Primary outcomes

  1. Edinburgh postnatal depression scale (EPDS)

    In the mindfulness and compassion based intervention group

    Time frame: Baseline

  2. Edinburgh postnatal depression scale (EPDS)

    In the TAU control group

    Time frame: Baseline

  3. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-treatment 8 weeks from baseline in intervention group

  4. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-treatment 8 weeks from baseline in TAU control group

  5. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  6. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-partum 3 months follow up in TAU control group

  7. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  8. Edinburgh postnatal depression scale (EPDS)

    Time frame: Post-partum 6 months follow up in TAU control group

Secondary outcomes

  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    In the mindfulness-based intervention applied face-to-face and TAU control group

    Time frame: Baseline

  2. M.I.N.I. International Neuropsychiatric Interview

    only if needed

    Time frame: baseline applied in TAU and in intervention group

  3. Client service receipt inventory (CSRI)

    In the mindfulness-based intervention applied face-to-face and TAU control group

    Time frame: Baseline

  4. Client service receipt inventory (CSRI)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  5. Client service receipt inventory (CSRI)

    Time frame: Post-partum 6 months follow up in TAU control group

  6. Medical data regarding delivery and breastfeeding

    In the mindfulness-based intervention applied face-to-face and TAU control group

    Time frame: 2 months after delivery

  7. Perceived Stress Scale (PSS)

    In the mindfulness and compassion based intervention group

    Time frame: Baseline

  8. Perceived Stress Scale (PSS)

    In the TAU control group

    Time frame: Baseline

  9. Perceived Stress Scale (PSS)

    Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

  10. Perceived Stress Scale (PSS)

    Time frame: Post-treatment 8 weeks from baseline in TAU control group

  11. Perceived Stress Scale (PSS)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  12. Perceived Stress Scale (PSS)

    Time frame: Post-partum 3 months follow up in TAU control group

  13. Perceived Stress Scale (PSS)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  14. Perceived Stress Scale (PSS)

    Time frame: Post-partum 6 weeks follow up in TAU control group

  15. Positive and negative affect (PANAS)

    In the mindfulness and compassion based intervention group

    Time frame: Baseline

  16. Positive and negative affect (PANAS)

    In the TAU control group

    Time frame: Baseline

  17. Positive and negative affect (PANAS)

    Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

  18. Positive and negative affect (PANAS)

    Time frame: Post-treatment 8 weeks from baseline in TAU control group

  19. Positive and negative affect (PANAS)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  20. Positive and negative affect (PANAS)

    Time frame: Post-partum 3 months follow up in TAU control group

  21. Positive and negative affect (PANAS)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  22. Positive and negative affect (PANAS)

    Time frame: Post-partum 6 months follow up in TAU control group

  23. Five Facets and factors of mindfulness (FFMQ)

    In the mindfulness and compassion based intervention group

    Time frame: Baseline

  24. Five Facets and factors of mindfulness (FFMQ)

    In the TAU control group

    Time frame: Baseline

  25. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

  26. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-treatment 8 weeks from baseline in TAU control group

  27. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  28. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-partum 3 months follow up in TAU control group

  29. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  30. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Post-partum 6 months follow up in TAU control group

  31. Self Compassion Scale (SCS)

    In the mindfulness and compassion based intervention group

    Time frame: Baseline

  32. Self Compassion Scale (SCS)

    In the TAU control group

    Time frame: Baseline

  33. Self Compassion Scale (SCS)

    In the mindfulness and compassion based intervention group

    Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

  34. Self Compassion Scale (SCS)

    Time frame: Post-treatment 8 weeks from baseline in TAU control group

  35. Self Compassion Scale (SCS)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  36. Self Compassion Scale (SCS)

    Time frame: Post-partum 3 months follow up in TAU control group

  37. Self Compassion Scale (SCS)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  38. Self Compassion Scale(SCS)

    Time frame: Post-partum 6 months follow up in TAU control group

  39. Parental Evaluation Scale (EEP)

    Time frame: Post-partum 3 months follow up in 8 weeks intervention group

  40. Parental Evaluation Scale (EEP)

    Time frame: Post-partum 3 months follow up in TAU control group

  41. Parental Evaluation Scale (EEP)

    Time frame: Post-partum 6 months follow up in 8 weeks intervention group

  42. Parental Evaluation Scale (EEP)

    Time frame: Post-partum 6 months follow up in TAU control group

07

Study locations

1 site
  • Universidad Nacional de Educacion a Distancia
    Valladolid, 47013, Spain
08

References and documents

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. PubMed 20339571 ↗
  • 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. PubMed 29051821 ↗
  • 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. PubMed 28499376 ↗
  • 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. PubMed 31779683 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03247491
Lead sponsor
Javier Garcia Campayo
Collaborators
Universidad Nacional de Educación a Distancia
Responsible party
Javier Garcia Campayo (Co-director of Olga Sacristán´s (principal investigator) ph dissertation, Hospital Miguel Servet) — Sponsor-investigator
First posted
Aug 11, 2017
Start date
Oct 1, 2017
Primary completion
Oct 2, 2019
Completion
Dec 1, 2019
Last update
Dec 3, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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