Pregnancy, Childbirth and Postpartum
Conditions
Keywords
Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress
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: 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.
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.
Sponsors
Universidad Nacional de Educación a Distancia
Javier Garcia Campayo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh postnatal depression scale (EPDS) | Baseline | In the mindfulness and compassion based intervention group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | Baseline | In the mindfulness-based intervention applied face-to-face and TAU control group |
| M.I.N.I. International Neuropsychiatric Interview | baseline applied in TAU and in intervention group | only if needed |
| Client service receipt inventory (CSRI) | Baseline | In the mindfulness-based intervention applied face-to-face and TAU control group |
| Medical data regarding delivery and breastfeeding | 2 months after delivery | In the mindfulness-based intervention applied face-to-face and TAU control group |
| Five Facets and factors of mindfulness (FFMQ) | Baseline | In the mindfulness and compassion based intervention group |
| Positive and negative affect (PANAS) | Baseline | In the mindfulness and compassion based intervention group |
| Self Compassion Scale (SCS) | Baseline | In the mindfulness and compassion based intervention group |
| Self Compassion Scale(SCS) | Post-partum 6 months follow up in TAU control group | — |
| Parental Evaluation Scale (EEP) | Post-partum 3 months follow up in 8 weeks intervention group | — |
| Perceived Stress Scale (PSS) | Baseline | In the mindfulness and compassion based intervention group |
Countries
Spain
Outcome results
None listed