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

University of Aarhus

Status: Enrolling

Conditions: Perinatal Mental Health; Pregnancy Related

Treatments: Behavioral: Prenatal mindfulness-based stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT05300646

2554

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 238 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Prenatal mindfulness-based stress reduction

Treatment as usual

No Intervention group

Description:

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.