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Completed

NCT Number: NCT03247491

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

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.

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Key information

Conditions

Pregnancy, Childbirth and Postpartum

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Nacional de Educacion a Distancia

Valladolid, 47013, Spain

About this 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.

There will be two groups:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

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.

Primary outcomes

  1. Edinburgh postnatal depression scale (EPDS)

    Time frame: Baseline

    In the mindfulness and compassion based intervention group

  2. Edinburgh postnatal depression scale (EPDS)

    Time frame: Baseline

    In the TAU control group

  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

    Time frame: Baseline

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

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

    Time frame: baseline applied in TAU and in intervention group

    only if needed

  3. Client service receipt inventory (CSRI)

    Time frame: Baseline

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

  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

    Time frame: 2 months after delivery

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

  7. Perceived Stress Scale (PSS)

    Time frame: Baseline

    In the mindfulness and compassion based intervention group

  8. Perceived Stress Scale (PSS)

    Time frame: Baseline

    In the TAU control group

  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)

    Time frame: Baseline

    In the mindfulness and compassion based intervention group

  16. Positive and negative affect (PANAS)

    Time frame: Baseline

    In the TAU control group

  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)

    Time frame: Baseline

    In the mindfulness and compassion based intervention group

  24. Five Facets and factors of mindfulness (FFMQ)

    Time frame: Baseline

    In the TAU control group

  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)

    Time frame: Baseline

    In the mindfulness and compassion based intervention group

  32. Self Compassion Scale (SCS)

    Time frame: Baseline

    In the TAU control group

  33. Self Compassion Scale (SCS)

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

    In the mindfulness and compassion based 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

Sponsors and collaborators

Lead sponsor

Javier Garcia Campayo

Other

Collaborators

  • Universidad Nacional de Educación a Distancia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.