Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.

NCT05300646 | Unknown

• 1 other identifier: 2554
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. In more detail, the primary outcome is to estimate the effect of prenatal Mindfulness-Based Stress Reduction (MBSR) as an add-on to usual care on mental well-being when compared to usual care alone. Second, to estimate the effect of prenatal MBSR on perceived stress and symptoms of depression and anxiety, and third to explore the effect on maternal bonding and childbirth, e.g. gestational age and experience of childbirth. Finally, to examine the mediating effect of mindfulness and self-compassion on the primary outcome.

Conditions

Perinatal Mental Health; Pregnancy Related

Keywords

Mindfulness; Mindfulness-based stress reduktion; MBSR; Perinatal mental health; Self-compassion

Outcome Measures

Primary Outcomes (1)

• The World Health Organization - Five Well-Being Index (WHO-5)

  The WHO-5 is a global rating scale measuring subjective well-being and consists of five statements and the respondent is asked to rate how well each of the statements applies to her when considering the last 14 days. Each item is scored from 5 "all of the time" to 0 "none of the time". Final scores range from 0 - 100 with higher scores representing greater well-being.

  From baseline to 6 months after completion of the intervention.

Secondary Outcomes (4)

• The Depression Anxiety Stress Scales (DASS-21)

  From baseline to 6 months after completion of the intervention.

• The Edinburgh Depression Scale (EDS)

  From baseline to 6 months after completion of the intervention.

• The Five-Facet Mindfulness Questionnaire (FFMQ)

  From baseline to 6 months after completion of the intervention.

• The Self-Compassion Scale (SCS)

  From baseline to 6 months after completion of the intervention.

Other Outcomes (2)

• The Maternal Antenatal Attachment Scale (MAAS)

  From baseline to completion of the intervention.

• The Childbirth Experience Questionnaire (CEQ)

  At 3 months after completion of the intervention.

Study Arms (2)

Intervention

EXPERIMENTAL

The prenatal MBSR program is an adaptation of MBSR. Details on the adaptation process is described in Skovbjerg S et al. Pilot and feasibility studies, 2021 Jun 3; 7 (1):118. Prenatal MBSR include nine weekly two-hour classes and is delivered in a combination between physical attendance and live-online teaching. The recommended time for daily mindfulness training between sessions is 15 minutes a day with options for longer practice. Audio recordings with guided meditations and a video with yoga programs for pregnancy is provided for home practice.

Behavioral: Prenatal mindfulness-based stress reduction

Treatment as usual

NO INTERVENTION

Standard clinical practice, usual care (TAU), consists of an average of six routine pregnancy visits to the outpatient antenatal clinic at Copenhagen University Hospital, Hvidovre and to a General Practitioner. Routine pregnancy visits involves primarily preventive counselling by midwifes, and in some cases consultations with a physician or social worker throughout pregnancy and the early post-partum period. In some cases, usual care may include consultations with a psychologist, although usually limited to a few sessions, and in more severe cases referral to psychiatric treatment.

Interventions

Prenatal mindfulness-based stress reduction BEHAVIORAL

An adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood.

Intervention

Eligibility Criteria

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

You may qualify if:

• Estimated due date no sooner than three months from start of the intervention. This criterion is included in order for the women to be able to complete the intervention before their due date.
• Eighteen + years of age.
• Speak and write Danish.
• Written informed consent to study criteria.

You may not qualify if:

• Active substance dependence.
• Psychotic disorders (e.g. schizophrenia or bipolar disorder).
• Suicidality.

Sponsors & Collaborators

• University of Aarhus: lead
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (2)

Copenhagen University Hospital, Hvidovre

Copenhagen, Capital Region, 2650, Denmark

RECRUITING

The Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University

Aarhus C, 8000, Denmark

RECRUITING

Related Publications (1)

• Skovbjerg S, Sumbundu A, Kolls M, Kjaerbye-Thygesen A, Fjorback LO. The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. BMC Complement Med Ther. 2023 Oct 14;23(1):364. doi: 10.1186/s12906-023-04194-3.

  PMID: 37838672 DERIVED

Central Study Contacts

Sine Skovbjerg, PhD

CONTACT

+ 45 26357227; sine.skovbjerg@clin.au.dk

Lone Overby Fjorback, PhD

CONTACT

+ 45 93521996; lone-overby.fjorback@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group affiliation will be concealed for the researcher performing the statistical analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 29, 2022
• Study Start: March 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)