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

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ClinicalTrials.gov Identifier: NCT03247491
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Universidad Nacional de Educación a Distancia
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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.

Condition or disease Intervention/treatment Phase
Pregnancy, Childbirth and Postpartum Behavioral: Mindfulness Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 2, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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).



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247491


Locations
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Spain
Universidad Nacional de Educacion a Distancia
Valladolid, Spain, 47013
Sponsors and Collaborators
Javier Garcia Campayo
Universidad Nacional de Educación a Distancia

Publications:
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, L.G. & Dymond, M. (2014). Mindfulness-Based Childbirth and Parenting (MBCP): A health promotion model of childbirth education? International Journal of Birth and Parenting Education, 2(2), 34-37.

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Responsible Party: Javier Garcia Campayo, Co-director of Olga Sacristán´s (principal investigator) ph dissertation, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT03247491     History of Changes
Other Study ID Numbers: 50/2014/04
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
Mindfulness
Compassion
Depression during Pregnancy and Postpartum
Prevention
Stress
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms