Clinical trial NCT03247491: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Childbirth and Postpartum
Keywords: Mindfulness
Compassion
Depression during Pregnancy and Postpartum
Prevention
Stress
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de Educación a Distancia
First posted: 2017-08-11
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Baseline
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Baseline
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-treatment 8 weeks from baseline in intervention group
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Edinburgh postnatal depression scale (EPDS)
timeFrame: Post-partum 6 months follow up in TAU control group
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: M.I.N.I. International Neuropsychiatric Interview
timeFrame: baseline applied in TAU and in intervention group
measure: Client service receipt inventory (CSRI)
timeFrame: Baseline
measure: Client service receipt inventory (CSRI)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Client service receipt inventory (CSRI)
timeFrame: Post-partum 6 months follow up in TAU control group
measure: Medical data regarding delivery and breastfeeding
timeFrame: 2 months after delivery
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Perceived Stress Scale (PSS)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Perceived Stress Scale (PSS)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
timeFrame: Post-partum 6 weeks follow up in TAU control group
measure: Positive and negative affect (PANAS)
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Positive and negative affect (PANAS)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Positive and negative affect (PANAS)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
timeFrame: Post-partum 6 months follow up in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Baseline
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Baseline
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Post-partum 6 months follow up in TAU control group
measure: Self Compassion Scale (SCS)
timeFrame: Baseline
measure: Self Compassion Scale (SCS)
timeFrame: Baseline
measure: Self Compassion Scale (SCS)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Self Compassion Scale (SCS)
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Self Compassion Scale (SCS)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Self Compassion Scale (SCS)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Self Compassion Scale (SCS)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Self Compassion Scale(SCS)
timeFrame: Post-partum 6 months follow up in TAU control group
measure: Parental Evaluation Scale (EEP)
timeFrame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Parental Evaluation Scale (EEP)
timeFrame: Post-partum 3 months follow up in TAU control group
measure: Parental Evaluation Scale (EEP)
timeFrame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Parental Evaluation Scale (EEP)
timeFrame: Post-partum 6 months follow up in TAU control group
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad Nacional de Educacion a Distancia
Study officials:
References:
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.
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.
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.
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.
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.
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.