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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
122
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.
Universidad Nacional de Educacion a Distancia
Valladolid, Spain
Edinburgh postnatal depression scale (EPDS)
In the mindfulness and compassion based intervention group
Time frame: Baseline
Edinburgh postnatal depression scale (EPDS)
In the TAU control group
Time frame: Baseline
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 6 months follow up in TAU control group
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
M.I.N.I. International Neuropsychiatric Interview
only if needed
Time frame: 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
Time frame: Baseline
Client service receipt inventory (CSRI)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Client service receipt inventory (CSRI)
Time frame: 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
Time frame: 2 months after delivery
Perceived Stress Scale (PSS)
In the mindfulness and compassion based intervention group
Time frame: Baseline
Perceived Stress Scale (PSS)
In the TAU control group
Time frame: Baseline
Perceived Stress Scale (PSS)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Perceived Stress Scale (PSS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-partum 3 months follow up in TAU control group
Perceived Stress Scale (PSS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-partum 6 weeks follow up in TAU control group
Positive and negative affect (PANAS)
In the mindfulness and compassion based intervention group
Time frame: Baseline
Positive and negative affect (PANAS)
In the TAU control group
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Positive and negative affect (PANAS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: Post-partum 3 months follow up in TAU control group
Positive and negative affect (PANAS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: 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
Time frame: Baseline
Five Facets and factors of mindfulness (FFMQ)
In the TAU control group
Time frame: Baseline
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 3 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)
In the mindfulness and compassion based intervention group
Time frame: Baseline
Self Compassion Scale (SCS)
In the TAU control group
Time frame: Baseline
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
Self Compassion Scale (SCS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Self Compassion Scale (SCS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Self Compassion Scale (SCS)
Time frame: Post-partum 3 months follow up in TAU control group
Self Compassion Scale (SCS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Self Compassion Scale(SCS)
Time frame: Post-partum 6 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 3 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 6 months follow up in TAU control group
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.