Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health

NCT02441595 | Completed

• 1 other identifier: K63103043a
• Study Type: interventional
• Target: 193
• Locations: 0 countries
• Sites: N/A

Brief 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 infant-caregiver attachment.

Conditions

Parent-Child Relations; Depression, Postpartum; Stress, Physiological; Stress, Psychological

Outcome Measures

Primary Outcomes (2)

• 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

• Parent Child Early Relational Assessment

  Measures infant and primary caregiver attachment

  When infant is 12 months old

Secondary Outcomes (13)

• Change in Maternal heart rate variability

  from baseline to 9 weeks (post-intervention)

• Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10

  from baseline to 9 weeks (post-intervention)

• Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s

  from baseline to 9 weeks (post-intervention)

• Change in Maternal serum levels of Corticotrophin Releasing Hormone

  from baseline to 9 weeks (post-intervention)

• Change in Edinburgh Postnatal Depression Scale

  From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old

Other Outcomes (1)

• Qualitative study of perceived experience of MBCP-intervention

  When participants infant is 3-4 months old

Study Arms (2)

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.

Behavioral: MBCP

Control condition

ACTIVE COMPARATOR

Participants in the control condition are being offered a standardized course in psychoprophylaxis.

Behavioral: Psychoprophylaxis

Interventions

MBCP BEHAVIORAL

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.

MBCP intervention

Psychoprophylaxis BEHAVIORAL

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.

Control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (3)

• 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.

  PMID: 37038176 DERIVED

• Lonnberg 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.

  PMID: 31733457 DERIVED

• Lonnberg 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.

  PMID: 30509218 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Stress, Psychological

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eva Nissen, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M PH

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08