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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pregnancy, High Risk

Intervention / Treatment
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* Behavioral: Prenatal MBSR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prenatal MBSR<br>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. | Behavioral: Prenatal MBSR<br>* Prenatal MBSR is an adaptation to the original MBSR program. The essential program elements characterizing MBSR is maintained and integrated with the particular context and specific needs of this group of pregnant women. Adaptations to the MBSR program draw upon both empirical data as well as existing research and theory.<br>* Other names: MBSR;|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Perceived Stress Scale | The Perceived Stress Scale 10-item version (PSS-10) is a global measure of the perception of stress. Scores range from 0 - 40 with higher scores pointing to more perceived stress. The Danish consensus version of the PSS-10 can be used in clinical research settings and has good psychometric properties. | From baseline to three-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Edinburgh Depression Scale | The Edinburgh Depression Scale (EDS) is a widely used screening questionnaire containing questions on how the respondent has felt in the past seven days. Scores range from 0 - 30. A higher score points to more depressive symptoms, and a score of 11 has been suggested as the optimal cut-off for depression according to both DSM-5 and ICD-10 criteria The EDS has been validated as a screening instrument for prenatal and postpartum depression showing good psychometric properties. | From baseline to three-months follow-up | 
| The Depression, Anxiety Stress Scales | The Depression, Anxiety Stress Scales - 21 (DASS-21) has three subscales designed to discriminate between depression, anxiety and stress in the last week. The DASS excludes somatic items such as sleep disturbance, lack of energy and poor concentration, which may not be valid markers in pregnancy or the postpartum period. 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 subscale and higher scores point to more symptoms of stress, anxiety or depression. | From baseline to three-months follow-up | 
| WHO-5 | The WHO-5 is a short and generic global rating scale measuring subjective well-being. It consists of five statements and the respondent is asked to rate how well each of the statements applies to him or her when considering the last 14 days. Final scores range from 0 - 100 with higher scores representing greater well-being. The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials and has been applied successfully across a wide range of study fields. | From baseline to three-months follow-up | 
| Prenatal Reflective functioning | Parental reflective functioning refers to the caregiver's capacity to reflect upon his/her own internal mental experiences as well as those of the child. The Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) is a recently developed 14-item questionnaire for assessing early parental mentalizing capacity. Responses are rated on a scale from 7 (strongly agree) to 1 (strongly disagree). The raw scores range from 14 - 98 and the index sum from 1 - 7. Higher score indicates higher prenatal mentalizing capacity. The P-PRFQ has shown good initial psychometric properties. | From baselineResponses are rated on a scale from 7 (strongly agree) to 1 (strongly disagree). to three-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal mental health, Pregnancy, High Risk, Mindfulness, Mindfulness-based stress reduction, MBSR, Prenatal mindfulness-based stress reduction