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

March 18, 2022 updated by: University of Aarhus

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Prenatal mindfulness-based stress reduction
An adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The World Health Organization - Five Well-Being Index (WHO-5)
Time Frame: From baseline to 6 months after completion of the intervention.
The WHO-5 is a global rating scale measuring subjective well-being and consists of five statements and the respondent is asked to rate how well each of the statements applies to her when considering the last 14 days. Each item is scored from 5 "all of the time" to 0 "none of the time". Final scores range from 0 - 100 with higher scores representing greater well-being.
From baseline to 6 months after completion of the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Depression Anxiety Stress Scales (DASS-21)
Time Frame: From baseline to 6 months after completion of the intervention.
DASS-21 has three sub-scales designed to discriminate between depression, anxiety and stress in the last week. Each sub-scale include seven items. Response to each item is rated on a four-point Likert scale ranging from 'never' to 'very much/most of the time'. Scores are calculated for each sub-scale and higher scores point to more symptoms of stress, anxiety or depression.
From baseline to 6 months after completion of the intervention.
The Edinburgh Depression Scale (EDS)
Time Frame: From baseline to 6 months after completion of the intervention.
The EDS is a screening questionnaire for depression in the perinatal period that contains 10 questions on how the respondent has felt in the past seven days with each item scored 0 - 3 yielding a maximum score of 30. A higher score points to more depressive symptoms.
From baseline to 6 months after completion of the intervention.
The Five-Facet Mindfulness Questionnaire (FFMQ)
Time Frame: From baseline to 6 months after completion of the intervention.
The FFMQ assesses five general facets of being mindful in daily life: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Items are rated on a five-point Likert scale ranging from 1 "never or very rarely true" to 5 "very often or always true". Higher scores suggest higher levels of mindfulness.
From baseline to 6 months after completion of the intervention.
The Self-Compassion Scale (SCS)
Time Frame: From baseline to 6 months after completion of the intervention.
The SCS measures the ability to have a healthy stand towards oneself that does not involve evaluations of self-worth. The scale consists of 12 items and responses are given on a 5-point scale from ranging from 1 "almost never" to 5 "almost always". Higher scores indicate more self-compassionate behavior.
From baseline to 6 months after completion of the intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Maternal Antenatal Attachment Scale (MAAS)
Time Frame: From baseline to completion of the intervention.
MASS is a measure of the maternal-fetal bond that consists of 19 items covering two sub-scales: "quality of attachment" (11 items) and "time spent in attachment mode" (8 items) 53. All items are scored on a five-point scale. The minimum score for the total MAAS is 19 and the maximum is 95. The scores for the sub-scales range between 11 and 50 (Quality of attachment) and between 8 and 40 (Time spent in attachment mode). High scores reflect, respectively, a positive quality of attachment and a high intensity of preoccupation with the fetus.
From baseline to completion of the intervention.
The Childbirth Experience Questionnaire (CEQ)
Time Frame: At 3 months after completion of the intervention.
The CEQ assess different aspects of childbirth experience 56. The CEQ contains 22 statements assessing four domains of the childbirth experience; own capacity, professional support, participation, and perceived safety. For 19 of the items the response format is a 4-point Likert scale whereas the last three items use a visual analogue scale (VAS). Higher scores reflect a more positive birth experience.
At 3 months after completion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Copenhagen University Hospital, Hvidovre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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