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

Pregnancy Related Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300646
• Other study ID #: 2554
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: University of Aarhus
• Contact: Sine Skovbjerg, PhD
• Phone: + 45 26357227
• Email: sine.skovbjerg[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Perinatal Mental Health
• Pregnancy Related

Intervention

Behavioral:
• Prenatal mindfulness-based stress reduction
An adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood.

Locations

Country	Name	City	State
Denmark	The Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University	Aarhus C
Denmark	Copenhagen University Hospital, Hvidovre	Copenhagen	Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Maternal Antenatal Attachment Scale (MAAS)	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.
Other	The Childbirth Experience Questionnaire (CEQ)	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.
Primary	The World Health Organization - Five Well-Being Index (WHO-5)	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	The Depression Anxiety Stress Scales (DASS-21)	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.
Secondary	The Edinburgh Depression Scale (EDS)	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.
Secondary	The Five-Facet Mindfulness Questionnaire (FFMQ)	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.
Secondary	The Self-Compassion Scale (SCS)	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.