An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.

University of Aarhus

Status: Completed

Conditions: Pregnancy, High Risk

Treatments: Behavioral: Prenatal MBSR

Study type: Interventional

Funder types: Other

Identifiers

NCT04571190

07121971

Details and patient eligibility

About

This protocol is for a feasibility study of an adapted mindfulness-based stress reduction (MBSR) program for high-risk pregnant women. The aim is to address the need for more evidence-based options for mental healthcare in pregnancy. MBSR has good evidence in reducing stress, anxiety and depression in both clinical and non-clinical populations, but has not yet been adapted for high-risk pregnancies. The purpose is to evaluate the feasibility, acceptability and potential intervention effects of an adapted MBSR program compared to usual care to inform a randomized controlled trial.

Full description

This protocol is for a feasibility study of an adapted mindfulness-based stress reduction (MBSR) program for high-risk pregnant women attending a hospital-based outpatient clinic specialized in antenatal care for high-risk pregnancies. A history of a mental disorder and/or severe psychosocial problems that may pose a risk to the health of the mother and fetus are reasons for referral to the clinic. The protocol is part of the Good start to family life study and the primary aim is to address the need of high-risk pregnant women and care providers for a wider array of evidence-based options to address prenatal mental health care needs. Mindfulness-based interventions are promising interventions for mental disorders with performance equivalent to evidence-based treatments, such as cognitive behavioral therapy and antidepressant medication for some disorders. Moreover, it is an acceptable intervention for pregnant women. A history of any psychopathology or psychosocial adversities, including low social support and abuse, are predictors of mental disorders during and after pregnancy with little diagnostic specificity. Mental disorders or symptoms often continue after birth emphasizing the need for early intervention and prevention. The intention of teaching mindfulness to this group of pregnant women is thus to engage and strengthen their internal resources for optimizing recovery or prevent relapse of mental health disorders during the perinatal period, and to teach skills that may aid the formation of a healthy mother-child relationship.

The objectives of the feasibility study are thus to assess the: (1) acceptance of study participation among at-risk pregnant women; (2) acceptance of allocated interventions; (3) number of referrals to psychiatric treatment during the study period; (4) risk of bias: loss to follow-up in the study arms; acceptance and compliance with the intervention, i.e. attending ≥ 5 sessions; (5) the extent of missing data leading to missing outcomes, and (6) indications of potential intervention effects. The adapted MBSR program will be referred to as prenatal MBSR.

The study is conducted at Copenhagen University Hospital, Hvidovre, Denmark. The design is a single-center feasibility trial comparing prenatal MBSR as add on to usual care with a waitlist control group receiving usual care alone. High-risk pregnant women around 18 weeks gestation (n = 60) will be recruited for the study provided that they are not diagnosed with a major psychiatric illness, psychosis, current substance abuse or suicidality. Participants will be randomized in a1:1 ratio to prenatal MBSR or usual care.

Teaching the skills of mindfulness meditation to a vulnerable group of pregnant women could prove as a viable and non-pharmacological approach to improve mental health and provide support in the transition to parenthood. The outcomes of the feasibility study will inform the design of a fully powered randomized controlled trial.

Enrollment: 73 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Due date no sooner than three months from start of the mindfulness program
• able to 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

• concurrent substance abuse
• schizophrenia, psychosis, PTSD, schizotypal personality disorder or other major psychiatric disorder
• suicidality

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Prenatal MBSR

Experimental group

Description:

The prenatal MBSR program consists of nine two-hour sessions including teachings in mindfulness meditation and yoga. The program is taught by an experienced MBSR instructor with relevant clinical expertise.

Treatment:

Behavioral: Prenatal MBSR

Usual care

No Intervention group

Description:

Standard clinical practice, usual care (TAU), imply routine pregnancy visits to the outpatient antenatal clinic at Copenhagen University Hospital, Hvidovre and to a General Practitioner. Usual care include a multidisciplinary approach involving preventive counselling by midwifes, physicians and social workers throughout the pregnancy and follow-up until the early post-partum period.