Stress, Psychological Clinical Trial
— MBCPOfficial title:
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
NCT number | NCT02441595 |
Other study ID # | K63103043a |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | August 2018 |
Verified date | August 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to explore if an intervention using Mindfulness Based Childbirth and Parenting education (MBCP) targeted to stressed pregnant women is effective in: 1) reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3) preparing the mother for labor and 4) promoting positive infant-caregiver attachment.
Status | Completed |
Enrollment | 193 |
Est. completion date | August 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: The study is open to pregnant women in the late second or early third trimester of pregnancy who are screened with a short questionnaire: Those who report high levels of perceived stress, and/or previous mental health issues such as depression/anxiety, and/or childhood neglect are included. Participants must also speak fluent Swedish. Exclusion Criteria: Actively psychotic, having previous experience of mindfulness, third wave cognitive behavioral therapies, or related practices. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Qualitative study of perceived experience of MBCP-intervention | Individual in-depth interviews regarding the participants experiences of MBCP | When participants infant is 3-4 months old | |
Primary | Change in Perceived Stress Scale 14-item | A scale measuring perception of stressful experiences during the past month | From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old | |
Primary | Parent Child Early Relational Assessment | Measures infant and primary caregiver attachment | When infant is 12 months old | |
Secondary | Change in Maternal heart rate variability | Examined through ECG | from baseline to 9 weeks (post-intervention) | |
Secondary | Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10 | from baseline to 9 weeks (post-intervention) | ||
Secondary | Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s | from baseline to 9 weeks (post-intervention) | ||
Secondary | Change in Maternal serum levels of Corticotrophin Releasing Hormone | from baseline to 9 weeks (post-intervention) | ||
Secondary | Change in Edinburgh Postnatal Depression Scale | A 10-item scale measuring anxiety and depression | From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old | |
Secondary | Change in Positive States of Minds | A six-item scale measuring different positive emotional and cognitive experiences | From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old | |
Secondary | Change in Five Facets of Mindfulness | 29-item scale measuring mindfulness | From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old | |
Secondary | Labour records | Labour records will be assessed as regards to labour complications and use of pain relief and labour induction | 1 week after giving birth | |
Secondary | Infant serum levels of the cytokines interleukin-6 and interleukin-10 | Levels will be analyzed from dried PKU blood spots | At age 2-3 days | |
Secondary | Infant serum levels of Brain Derived Neurotrophic Factor-S | Levels will be analyzed from dried PKU blood spots | At age 2-3 days | |
Secondary | Infant serum levels of Corticotrophin Releasing Hormone | Levels will be analyzed from dried PKU blood spots | At age 2-3 days | |
Secondary | Infant Heart Rate Variability | Examined through ECG | At age 12 months | |
Secondary | Pregnancy Interveiw | Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents. | Baseline measure |
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