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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Background A history of psychopathology or psychosocial adversities are risk factors for mental disorders in the perinatal period. Mental disorders in pregnancy can adversely affect the developing fetus, which call for early prevention. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. The aim of this study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psychosocially highly vulnerable group of pregnant women.

Methods/design Pregnant women (n = 238) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark will be recruited for the study. The design is a single-center, parallel group, randomized controlled trial, with an adapted MBSR program as add on to usual care. The primary outcome is mental wellbeing. Secondary and exploratory outcomes include stress, anxiety, depression, mindfulness, compassion, antenatal attachment and childbirth experience. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care.

Implications for perinatal mental health Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health during pregnancy, reduce stress and support the transition to parenthood. The MBSR program does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health.

Conditions

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Perinatal Mental Health Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-center, parallel group, randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Group affiliation will be concealed for the researcher performing the statistical analyses.

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Prenatal mindfulness-based stress reduction

Intervention Type BEHAVIORAL

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

Treatment as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prenatal mindfulness-based stress reduction

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
* Available for group intervention scheduled sessions. Being unavailable for two or more sessions is reason for exclusion from study participation.
* Written informed consent to study criteria.