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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

Primary Purpose

Pregnancy, Childbirth and Postpartum

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Javier Garcia Campayo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy, Childbirth and Postpartum focused on measuring Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Nacional de Educacion a Distancia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No intervention

Arm Description

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.

Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).

Outcomes

Primary Outcome Measures

Edinburgh postnatal depression scale (EPDS)
In the mindfulness and compassion based intervention group
Edinburgh postnatal depression scale (EPDS)
In the TAU control group
Edinburgh postnatal depression scale (EPDS)
Edinburgh postnatal depression scale (EPDS)
Edinburgh postnatal depression scale (EPDS)
Edinburgh postnatal depression scale (EPDS)
Edinburgh postnatal depression scale (EPDS)
Edinburgh postnatal depression scale (EPDS)

Secondary Outcome Measures

Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the mindfulness-based intervention applied face-to-face and TAU control group
M.I.N.I. International Neuropsychiatric Interview
only if needed
Client service receipt inventory (CSRI)
In the mindfulness-based intervention applied face-to-face and TAU control group
Client service receipt inventory (CSRI)
Client service receipt inventory (CSRI)
Medical data regarding delivery and breastfeeding
In the mindfulness-based intervention applied face-to-face and TAU control group
Perceived Stress Scale (PSS)
In the mindfulness and compassion based intervention group
Perceived Stress Scale (PSS)
In the TAU control group
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Positive and negative affect (PANAS)
In the mindfulness and compassion based intervention group
Positive and negative affect (PANAS)
In the TAU control group
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Five Facets and factors of mindfulness (FFMQ)
In the mindfulness and compassion based intervention group
Five Facets and factors of mindfulness (FFMQ)
In the TAU control group
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Self Compassion Scale (SCS)
In the mindfulness and compassion based intervention group
Self Compassion Scale (SCS)
In the TAU control group
Self Compassion Scale (SCS)
In the mindfulness and compassion based intervention group
Self Compassion Scale (SCS)
Self Compassion Scale (SCS)
Self Compassion Scale (SCS)
Self Compassion Scale (SCS)
Self Compassion Scale(SCS)
Parental Evaluation Scale (EEP)
Parental Evaluation Scale (EEP)
Parental Evaluation Scale (EEP)
Parental Evaluation Scale (EEP)

Full Information

First Posted
August 9, 2017
Last Updated
December 1, 2019
Sponsor
Javier Garcia Campayo
Collaborators
Universidad Nacional de Educación a Distancia
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1. Study Identification

Unique Protocol Identification Number
NCT03247491
Brief Title
Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Javier Garcia Campayo
Collaborators
Universidad Nacional de Educación a Distancia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Childbirth and Postpartum
Keywords
Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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 Outcome Measure Information:
Title
Edinburgh postnatal depression scale (EPDS)
Description
In the mindfulness and compassion based intervention group
Time Frame
Baseline
Title
Edinburgh postnatal depression scale (EPDS)
Description
In the TAU control group
Time Frame
Baseline
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-treatment 8 weeks from baseline in intervention group
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-treatment 8 weeks from baseline in TAU control group
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Edinburgh postnatal depression scale (EPDS)
Time Frame
Post-partum 6 months follow up in TAU control group
Secondary Outcome Measure Information:
Title
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Description
In the mindfulness-based intervention applied face-to-face and TAU control group
Time Frame
Baseline
Title
M.I.N.I. International Neuropsychiatric Interview
Description
only if needed
Time Frame
baseline applied in TAU and in intervention group
Title
Client service receipt inventory (CSRI)
Description
In the mindfulness-based intervention applied face-to-face and TAU control group
Time Frame
Baseline
Title
Client service receipt inventory (CSRI)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Client service receipt inventory (CSRI)
Time Frame
Post-partum 6 months follow up in TAU control group
Title
Medical data regarding delivery and breastfeeding
Description
In the mindfulness-based intervention applied face-to-face and TAU control group
Time Frame
2 months after delivery
Title
Perceived Stress Scale (PSS)
Description
In the mindfulness and compassion based intervention group
Time Frame
Baseline
Title
Perceived Stress Scale (PSS)
Description
In the TAU control group
Time Frame
Baseline
Title
Perceived Stress Scale (PSS)
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Perceived Stress Scale (PSS)
Time Frame
Post-treatment 8 weeks from baseline in TAU control group
Title
Perceived Stress Scale (PSS)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Perceived Stress Scale (PSS)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Perceived Stress Scale (PSS)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Perceived Stress Scale (PSS)
Time Frame
Post-partum 6 weeks follow up in TAU control group
Title
Positive and negative affect (PANAS)
Description
In the mindfulness and compassion based intervention group
Time Frame
Baseline
Title
Positive and negative affect (PANAS)
Description
In the TAU control group
Time Frame
Baseline
Title
Positive and negative affect (PANAS)
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Positive and negative affect (PANAS)
Time Frame
Post-treatment 8 weeks from baseline in TAU control group
Title
Positive and negative affect (PANAS)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Positive and negative affect (PANAS)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Positive and negative affect (PANAS)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Positive and negative affect (PANAS)
Time Frame
Post-partum 6 months follow up in TAU control group
Title
Five Facets and factors of mindfulness (FFMQ)
Description
In the mindfulness and compassion based intervention group
Time Frame
Baseline
Title
Five Facets and factors of mindfulness (FFMQ)
Description
In the TAU control group
Time Frame
Baseline
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-treatment 8 weeks from baseline in TAU control group
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Post-partum 6 months follow up in TAU control group
Title
Self Compassion Scale (SCS)
Description
In the mindfulness and compassion based intervention group
Time Frame
Baseline
Title
Self Compassion Scale (SCS)
Description
In the TAU control group
Time Frame
Baseline
Title
Self Compassion Scale (SCS)
Description
In the mindfulness and compassion based intervention group
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Self Compassion Scale (SCS)
Time Frame
Post-treatment 8 weeks from baseline in TAU control group
Title
Self Compassion Scale (SCS)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Self Compassion Scale (SCS)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Self Compassion Scale (SCS)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Self Compassion Scale(SCS)
Time Frame
Post-partum 6 months follow up in TAU control group
Title
Parental Evaluation Scale (EEP)
Time Frame
Post-partum 3 months follow up in 8 weeks intervention group
Title
Parental Evaluation Scale (EEP)
Time Frame
Post-partum 3 months follow up in TAU control group
Title
Parental Evaluation Scale (EEP)
Time Frame
Post-partum 6 months follow up in 8 weeks intervention group
Title
Parental Evaluation Scale (EEP)
Time Frame
Post-partum 6 months follow up in TAU control group

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Universidad Nacional de Educacion a Distancia
City
Valladolid
ZIP/Postal Code
47013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20339571
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
29051821
Citation
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.
Results Reference
background
PubMed Identifier
28499376
Citation
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.
Results Reference
background
PubMed Identifier
31779683
Citation
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.
Results Reference
derived

Learn more about this trial

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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