Clinical trial NCT05300646: Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.
Official title: The Effect of an Adapted Mindfulness-Based Stress Reduction Program on Mental Health, Maternal Bonding and Birth Outcomes in Psycho-socially Vulnerable Pregnant Women: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Mental Health
Pregnancy Related
Keywords: Mindfulness
Mindfulness-based stress reduktion
MBSR
Perinatal mental health
Self-compassion
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2022-03-29
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, parallel group, randomized controlled trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The World Health Organization - Five Well-Being Index (WHO-5)
timeFrame: From baseline to 6 months after completion of the intervention.
Secondary outcomes:
measure: The Depression Anxiety Stress Scales (DASS-21)
timeFrame: From baseline to 6 months after completion of the intervention.
measure: The Edinburgh Depression Scale (EDS)
timeFrame: From baseline to 6 months after completion of the intervention.
measure: The Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: From baseline to 6 months after completion of the intervention.
measure: The Self-Compassion Scale (SCS)
timeFrame: From baseline to 6 months after completion of the intervention.
Other outcomes:
measure: The Maternal Antenatal Attachment Scale (MAAS)
timeFrame: From baseline to completion of the intervention.
measure: The Childbirth Experience Questionnaire (CEQ)
timeFrame: At 3 months after completion of the intervention.
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
state: Capital Region
city: Aarhus C
country: Denmark
facility: The Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University
Study officials:
References: