Parent-Child RelationsMBCPNCT02441595
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
A study testing MBCP and Psychoprophylaxis in people with Parent-Child Relations and Depression, Postpartum, run by Karolinska Institutet.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parent-Child Relations, Depression, Postpartum, Stress, Physiological
- What is being tested?
- MBCP and Psychoprophylaxis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
Read the detailed description
Sample: Pregnant women experiencing high levels of stress, and/or who previously have had periods of depression or anxiety, and/or who have had some childhood neglect, will be eligible for the study. A sample of 170 mothers and their partners recruited from antenatal clinics in Stockholm will be asked to participate. The participants in the study will be randomized to either treatment or control intervention. The study uses an experimental design with assessments at baseline and post-intervention as well as follow-ups at 3, 9 and 15 months post-partum. The intervention involves eight 2.5 h weekly group sessions in which exercises in mindfulness are practiced and associated theory is taught to increase metacognition, emotional regulation and body awareness. Participants in the control condition are being offered a standardized course in psychoprophylaxis.
Measurements - parental outcomes PSYCHOLOGICAL FUNCTIONING - 10 item Perceived Stress Scale [10]. Edinburgh Postnatal Depression Scale [11]. Positive States of Minds [12].
INTERVENTION ADHERENCE - Questions to assess intervention adherence. PHYSIOLOGICAL ASSESSMENTS - Heart Rate Variability (HRV) will be examined through ECG. The investigators hypothesize that the intervention will increase HRV in the pregnant women, thus providing an objective measure of stress. The investigators will test if women who receive the intervention during pregnancy have lower serum levels of the cytokines interleukin-6 and interleukin-10, Brain Derived Neurotrophic Factor-s, and Corticotrophin Releasing Hormone compared to the control group - physiological components that influence the fetus and are associated with immune response, hypothalamic-pituitary-adrenal axis functions, stress-related mood disorders and preterm delivery [13-16].
LABOUR - Labour records will be gathered from all participants.
Measurements - infants PHYSIOLOGICAL ASSESSMENTS - Heart Rate Variability (HRV) examined through ECG at 15 months of age. The investigators hypothesize that increased maternal HRV in the pregnancy will be associated with increased infant HRV. The investigators will also test if infants whose mothers have received the intervention have lower serum levels of the cytokines interleukin-6 and interleukin-10, Brain Derived Neurotrophic Factor-S, and Corticotrophin Releasing Hor-mone: Levels will be analyzed from PKU blood spots, routinely collected 3-4 days after birth.
INFANT SOCIAL AND EMOTIONAL FUNCTIONING - The attachment style of the infants will be assessed at age 15 months, using the standard Parent-Child Early Relational Assessment developed by Clark [17].
Data analysis: Appropriate methods will be applied to describe the sample. Hypothesis will be tested by multivariate repeated measures analysis of covariance (MANCOVA) with perceived stress as the primary outcome.
- Conditions
- Parent-Child Relations, Depression, Postpartum, Stress, Physiological, Stress, Psychological
- Being tested
- MBCP, Psychoprophylaxis
- Medical subject headings
- Depression, Postpartum, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCPBehavioural
Eight weekly sessions 2,5 h and homework 30 min/day. Practicing various mindfulness meditations coupled with practical skills and theory of birthing and parenting.
PsychoprophylaxisBehavioural
Three sessions 3h each, and practices to do at home. Practical skills of relaxation and breathing techniques for labor as well as knowledge of birthing and parenting.
| Study group | Role | What they receive |
|---|---|---|
| MBCP intervention | Experimental | The intervention involves eight 2.5 h weekly group sessions in which exercises in mindfulness are practiced and associated theory is taught to increase metacognition, emotional regulation and body awareness. Receives: Behavioral: MBCP |
| Control condition | Active comparator | Participants in the control condition are being offered a standardized course in psychoprophylaxis. Receives: Behavioral: Psychoprophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale 14-item
A scale measuring perception of stressful experiences during the past month
Measured: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Parent Child Early Relational Assessment
Measures infant and primary caregiver attachment
Measured: When infant is 12 months old
Secondary outcomes (13)
Change in Maternal heart rate variability
Examined through ECG
Measured: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Measured: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
Measured: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Measured: from baseline to 9 weeks (post-intervention)
Change in Edinburgh Postnatal Depression Scale
A 10-item scale measuring anxiety and depression
Measured: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Positive States of Minds
A six-item scale measuring different positive emotional and cognitive experiences
Measured: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Five Facets of Mindfulness
29-item scale measuring mindfulness
Measured: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Labour records
Labour records will be assessed as regards to labour complications and use of pain relief and labour induction
Measured: 1 week after giving birth
Infant serum levels of the cytokines interleukin-6 and interleukin-10
Levels will be analyzed from dried PKU blood spots
Measured: At age 2-3 days
Infant serum levels of Brain Derived Neurotrophic Factor-S
Levels will be analyzed from dried PKU blood spots
Measured: At age 2-3 days
Infant serum levels of Corticotrophin Releasing Hormone
Levels will be analyzed from dried PKU blood spots
Measured: At age 2-3 days
Infant Heart Rate Variability
Examined through ECG
Measured: At age 12 months
Pregnancy Interveiw
Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
Measured: Baseline measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunilla Lönnberg, Karolinska Institutet
- Investigators
- Eva Nissen, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441595
- Sponsor's protocol ID
- K63103043a
- Acronym
- MBCP
- Status last verified
- Aug 2018
- First submitted
- 4 May 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Radmark L, Osika W, Wallen MB, Nissen E, Lonnberg G, Branstrom R, Henje E, Gardner R, Fransson E, Karlsson H, Niemi M. Autonomic function and inflammation in pregnant women participating in a randomized controlled study of Mindfulness Based Childbirth and Parenting. BMC Pregnancy Childbirth. 2023 Apr 10;23(1):237. doi: 10.1186/s12884-023-05528-2.
PubMed 37038176Lonnberg G, Jonas W, Unternaehrer E, Branstrom R, Nissen E, Niemi M. Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. J Affect Disord. 2020 Feb 1;262:133-142. doi: 10.1016/j.jad.2019.10.048. Epub 2019 Oct 30.
PubMed 31733457Lonnberg G, Nissen E, Niemi M. What is learned from Mindfulness Based Childbirth and Parenting Education? - Participants' experiences. BMC Pregnancy Childbirth. 2018 Dec 3;18(1):466. doi: 10.1186/s12884-018-2098-1.
PubMed 30509218
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
- ClinicalTrials.gov ID
- NCT02441595
- Acronym / sponsor ID
- MBCP / K63103043a
- Conditions
- Parent-Child Relations, Depression, Postpartum, Stress, Physiological, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample: Pregnant women experiencing high levels of stress, and/or who previously have had periods of depression or anxiety, and/or who have had some childhood neglect, will be eligible for the study. A sample of 170 mothers and their partners recruited from antenatal clinics in Stockholm will be asked to participate. The participants in the study will be randomized to either treatment or control intervention. The study uses an experimental design with assessments at baseline and post-intervention as well as follow-ups at 3, 9 and 15 months post-partum. The intervention involves eight 2.5 h weekly group sessions in which exercises in mindfulness are practiced and associated theory is taught to increase metacognition, emotional regulation and body awareness. Participants in the control condition are being offered a standardized course in psychoprophylaxis.
Measurements - parental outcomes PSYCHOLOGICAL FUNCTIONING - 10 item Perceived Stress Scale [10]. Edinburgh Postnatal Depression Scale [11]. Positive States of Minds [12].
INTERVENTION ADHERENCE - Questions to assess intervention adherence. PHYSIOLOGICAL ASSESSMENTS - Heart Rate Variability (HRV) will be examined through ECG. The investigators hypothesize that the intervention will increase HRV in the pregnant women, thus providing an objective measure of stress. The investigators will test if women who receive the intervention during pregnancy have lower serum levels of the cytokines interleukin-6 and interleukin-10, Brain Derived Neurotrophic Factor-s, and Corticotrophin Releasing Hormone compared to the control group - physiological components that influence the fetus and are associated with immune response, hypothalamic-pituitary-adrenal axis functions, stress-related mood disorders and preterm delivery [13-16].
LABOUR - Labour records will be gathered from all participants.
Measurements - infants PHYSIOLOGICAL ASSESSMENTS - Heart Rate Variability (HRV) examined through ECG at 15 months of age. The investigators hypothesize that increased maternal HRV in the pregnancy will be associated with increased infant HRV. The investigators will also test if infants whose mothers have received the intervention have lower serum levels of the cytokines interleukin-6 and interleukin-10, Brain Derived Neurotrophic Factor-S, and Corticotrophin Releasing Hor-mone: Levels will be analyzed from PKU blood spots, routinely collected 3-4 days after birth.
INFANT SOCIAL AND EMOTIONAL FUNCTIONING - The attachment style of the infants will be assessed at age 15 months, using the standard Parent-Child Early Relational Assessment developed by Clark [17].
Data analysis: Appropriate methods will be applied to describe the sample. Hypothesis will be tested by multivariate repeated measures analysis of covariance (MANCOVA) with perceived stress as the primary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCP intervention | Experimental | Behavioral: MBCPThe intervention involves eight 2.5 h weekly group sessions in which exercises in mindfulness are practiced and associated theory is taught to increase metacognition, emotional regulation and body awareness. |
| Control condition | Active comparator | Behavioral: PsychoprophylaxisParticipants in the control condition are being offered a standardized course in psychoprophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCPEight weekly sessions 2,5 h and homework 30 min/day. Practicing various mindfulness meditations coupled with practical skills and theory of birthing and parenting. | Behavioural | MBCP intervention |
| PsychoprophylaxisThree sessions 3h each, and practices to do at home. Practical skills of relaxation and breathing techniques for labor as well as knowledge of birthing and parenting. | Behavioural | Control condition |
Primary outcome
Change in Perceived Stress Scale 14-item
Time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
A scale measuring perception of stressful experiences during the past month
Parent Child Early Relational Assessment
Time frame: When infant is 12 months old
Measures infant and primary caregiver attachment
13 secondary outcomes
Change in Maternal heart rate variability
Time frame: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Time frame: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
Time frame: from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Time frame: from baseline to 9 weeks (post-intervention)
Change in Edinburgh Postnatal Depression Scale
Time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Positive States of Minds
Time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Five Facets of Mindfulness
Time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Labour records
Time frame: 1 week after giving birth
Infant serum levels of the cytokines interleukin-6 and interleukin-10
Time frame: At age 2-3 days
Infant serum levels of Brain Derived Neurotrophic Factor-S
Time frame: At age 2-3 days
Infant serum levels of Corticotrophin Releasing Hormone
Time frame: At age 2-3 days
Infant Heart Rate Variability
Time frame: At age 12 months
Pregnancy Interveiw
Time frame: Baseline measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 37038176Radmark L, Osika W, Wallen MB, Nissen E, Lonnberg G, Branstrom R, Henje E, Gardner R, Fransson E, Karlsson H, Niemi M. Autonomic function and inflammation in pregnant women participating in a randomized controlled study of Mindfulness Based Childbirth and Parenting. BMC Pregnancy Childbirth. 2023 Apr 10;23(1):237. doi: 10.1186/s12884-023-05528-2.
- Derived from this study: PubMed 31733457Lonnberg G, Jonas W, Unternaehrer E, Branstrom R, Nissen E, Niemi M. Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. J Affect Disord. 2020 Feb 1;262:133-142. doi: 10.1016/j.jad.2019.10.048. Epub 2019 Oct 30.
- Derived from this study: PubMed 30509218Lonnberg G, Nissen E, Niemi M. What is learned from Mindfulness Based Childbirth and Parenting Education? - Participants' experiences. BMC Pregnancy Childbirth. 2018 Dec 3;18(1):466. doi: 10.1186/s12884-018-2098-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Nissen, Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing MBCP and Psychoprophylaxis in people with Parent-Child Relations and Depression, Postpartum, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale 14-item (time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441595, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.