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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Edinburgh postnatal depression scale (EPDS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No intervention
Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).
Experimental
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.
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-partum 6 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
时间窗: Baseline
In the mindfulness and compassion based intervention group
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
时间窗: Post-partum 6 months follow up in 8 weeks intervention group
次要结局
- M.I.N.I. International Neuropsychiatric Interview(baseline applied in TAU and in intervention group)
- Parental Evaluation Scale (EEP)(Post-partum 6 months follow up in TAU control group)
- Sociodemographic data Gender, age, marital status, education, occupation, economical level(Baseline)
- Medical data regarding delivery and breastfeeding(2 months after delivery)
- Positive and negative affect (PANAS)(Post-partum 6 months follow up in TAU control group)
- Self Compassion Scale (SCS)(Post-partum 6 months follow up in 8 weeks intervention group)
- Self Compassion Scale(SCS)(Post-partum 6 months follow up in TAU control group)
- Perceived Stress Scale (PSS)(Post-partum 6 weeks follow up in TAU control group)
- Five Facets and factors of mindfulness (FFMQ)(Post-partum 6 months follow up in TAU control group)
- Client service receipt inventory (CSRI)(Post-partum 6 months follow up in TAU control group)
- Positive and negative affect (PANAS)(Post-treatment 8 weeks from baseline in TAU control group)
- Positive and negative affect (PANAS)(Post-partum 3 months follow up in 8 weeks intervention group)
- Positive and negative affect (PANAS)(Post-partum 3 months follow up in TAU control group)
- Positive and negative affect (PANAS)(Post-partum 6 months follow up in 8 weeks intervention group)
- Positive and negative affect (PANAS)(Post-treatment 8 weeks from baseline in 8 weeks intervention group)
- Client service receipt inventory (CSRI)(Baseline)
- Client service receipt inventory (CSRI)(Post-partum 6 months follow up in 8 weeks intervention group)
- Perceived Stress Scale (PSS)(Baseline)
- Perceived Stress Scale (PSS)(Post-treatment 8 weeks from baseline in 8 weeks intervention group)
- Perceived Stress Scale (PSS)(Post-treatment 8 weeks from baseline in TAU control group)
- Perceived Stress Scale (PSS)(Post-partum 3 months follow up in 8 weeks intervention group)
- Perceived Stress Scale (PSS)(Post-partum 3 months follow up in TAU control group)
- Perceived Stress Scale (PSS)(Post-partum 6 months follow up in 8 weeks intervention group)
- Positive and negative affect (PANAS)(Baseline)
- Five Facets and factors of mindfulness (FFMQ)(Baseline)
- Five Facets and factors of mindfulness (FFMQ)(Post-treatment 8 weeks from baseline in 8 weeks intervention group)
- Five Facets and factors of mindfulness (FFMQ)(Post-treatment 8 weeks from baseline in TAU control group)
- Five Facets and factors of mindfulness (FFMQ)(Post-partum 3 months follow up in 8 weeks intervention group)
- Five Facets and factors of mindfulness (FFMQ)(Post-partum 3 months follow up in TAU control group)
- Five Facets and factors of mindfulness (FFMQ)(Post-partum 6 months follow up in 8 weeks intervention group)
- Self Compassion Scale (SCS)(Baseline)
- Self Compassion Scale (SCS)(Post-treatment 8 weeks from baseline in 8 weeks intervention group)
- Self Compassion Scale (SCS)(Post-treatment 8 weeks from baseline in TAU control group)
- Self Compassion Scale (SCS)(Post-partum 3 months follow up in 8 weeks intervention group)
- Self Compassion Scale (SCS)(Post-partum 3 months follow up in TAU control group)
- Parental Evaluation Scale (EEP)(Post-partum 3 months follow up in 8 weeks intervention group)
- Parental Evaluation Scale (EEP)(Post-partum 3 months follow up in TAU control group)
- Parental Evaluation Scale (EEP)(Post-partum 6 months follow up in 8 weeks intervention group)
研究者
Javier Garcia Campayo
Co-director of Olga Sacristán´s (principal investigator) ph dissertation
Hospital Miguel Servet