Clinical trial NCT04571190: An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.
Official title: An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women - a Protocol for a Randomized Feasibility Study in a Danish Hospital-based Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Keywords: Prenatal mental health
Pregnancy, High Risk
Mindfulness
Mindfulness-based stress reduction
MBSR
Prenatal mindfulness-based stress reduction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2020-09-30
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a single-center feasibility trial comparing prenatal MBSR as add on to usual care with usual care alone. Participants will be randomized in a 1:1 ratio to an intervention or waitlist control group. Participants in the waitlist control group will be offered participation in a MBSR program after a three months follow-up period. Mindfulness training in the control group will thus be initiated postnatal.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Perceived Stress Scale
timeFrame: From baseline to three-months follow-up
Secondary outcomes:
measure: The Edinburgh Depression Scale
timeFrame: From baseline to three-months follow-up
measure: The Depression, Anxiety Stress Scales
timeFrame: From baseline to three-months follow-up
measure: WHO-5
timeFrame: From baseline to three-months follow-up
measure: Prenatal Reflective functioning
timeFrame: From baselineResponses are rated on a scale from 7 (strongly agree) to 1 (strongly disagree). to three-months follow-up
Other outcomes:
measure: The Experiences Questionnaire: subscale for decentering
timeFrame: From baseline to three-months follow-up
measure: The Five Facet Mindfulness Questionnaire
timeFrame: From baseline to three-months follow-up
measure: Compassion
timeFrame: From baseline to three-months follow-up
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Amager-Hvidovre
state: Capital Region
Study officials:
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