Pregnancy, Childbirth and Postpartum Clinical Trial
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
| Verified date | December 2019 |
| Source | Hospital Miguel Servet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | December 1, 2019 |
| Est. primary completion date | October 2, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universidad Nacional de Educacion a Distancia | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Javier Garcia Campayo | Universidad Nacional de Educación a Distancia |
Spain,
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. Epub 2009 Oct 10. — View 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. — View 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. — View Citation
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.
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Edinburgh postnatal depression scale (EPDS) | In the mindfulness and compassion based intervention group | Baseline | |
| Primary | Edinburgh postnatal depression scale (EPDS) | In the TAU control group | Baseline | |
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-treatment 8 weeks from baseline in intervention group | ||
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-treatment 8 weeks from baseline in TAU control group | ||
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-partum 3 months follow up in TAU control group | ||
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Primary | Edinburgh postnatal depression scale (EPDS) | Post-partum 6 months follow up in TAU control group | ||
| Secondary | Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the mindfulness-based intervention applied face-to-face and TAU control group | Baseline | |
| Secondary | M.I.N.I. International Neuropsychiatric Interview | only if needed | baseline applied in TAU and in intervention group | |
| Secondary | Client service receipt inventory (CSRI) | In the mindfulness-based intervention applied face-to-face and TAU control group | Baseline | |
| Secondary | Client service receipt inventory (CSRI) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Client service receipt inventory (CSRI) | Post-partum 6 months follow up in TAU control group | ||
| Secondary | Medical data regarding delivery and breastfeeding | In the mindfulness-based intervention applied face-to-face and TAU control group | 2 months after delivery | |
| Secondary | Perceived Stress Scale (PSS) | In the mindfulness and compassion based intervention group | Baseline | |
| Secondary | Perceived Stress Scale (PSS) | In the TAU control group | Baseline | |
| Secondary | Perceived Stress Scale (PSS) | Post-treatment 8 weeks from baseline in 8 weeks intervention group | ||
| Secondary | Perceived Stress Scale (PSS) | Post-treatment 8 weeks from baseline in TAU control group | ||
| Secondary | Perceived Stress Scale (PSS) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Secondary | Perceived Stress Scale (PSS) | Post-partum 3 months follow up in TAU control group | ||
| Secondary | Perceived Stress Scale (PSS) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Perceived Stress Scale (PSS) | Post-partum 6 weeks follow up in TAU control group | ||
| Secondary | Positive and negative affect (PANAS) | In the mindfulness and compassion based intervention group | Baseline | |
| Secondary | Positive and negative affect (PANAS) | In the TAU control group | Baseline | |
| Secondary | Positive and negative affect (PANAS) | Post-treatment 8 weeks from baseline in 8 weeks intervention group | ||
| Secondary | Positive and negative affect (PANAS) | Post-treatment 8 weeks from baseline in TAU control group | ||
| Secondary | Positive and negative affect (PANAS) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Secondary | Positive and negative affect (PANAS) | Post-partum 3 months follow up in TAU control group | ||
| Secondary | Positive and negative affect (PANAS) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Positive and negative affect (PANAS) | Post-partum 6 months follow up in TAU control group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | In the mindfulness and compassion based intervention group | Baseline | |
| Secondary | Five Facets and factors of mindfulness (FFMQ) | In the TAU control group | Baseline | |
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-treatment 8 weeks from baseline in 8 weeks intervention group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-treatment 8 weeks from baseline in TAU control group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-partum 3 months follow up in TAU control group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Five Facets and factors of mindfulness (FFMQ) | Post-partum 6 months follow up in TAU control group | ||
| Secondary | Self Compassion Scale (SCS) | In the mindfulness and compassion based intervention group | Baseline | |
| Secondary | Self Compassion Scale (SCS) | In the TAU control group | Baseline | |
| Secondary | Self Compassion Scale (SCS) | In the mindfulness and compassion based intervention group | Post-treatment 8 weeks from baseline in 8 weeks intervention group | |
| Secondary | Self Compassion Scale (SCS) | Post-treatment 8 weeks from baseline in TAU control group | ||
| Secondary | Self Compassion Scale (SCS) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Secondary | Self Compassion Scale (SCS) | Post-partum 3 months follow up in TAU control group | ||
| Secondary | Self Compassion Scale (SCS) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Self Compassion Scale(SCS) | Post-partum 6 months follow up in TAU control group | ||
| Secondary | Parental Evaluation Scale (EEP) | Post-partum 3 months follow up in 8 weeks intervention group | ||
| Secondary | Parental Evaluation Scale (EEP) | Post-partum 3 months follow up in TAU control group | ||
| Secondary | Parental Evaluation Scale (EEP) | Post-partum 6 months follow up in 8 weeks intervention group | ||
| Secondary | Parental Evaluation Scale (EEP) | Post-partum 6 months follow up in TAU control group |