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An Adapted Mindfulness-based Stress Reduction Program for High-risk Pregnancies

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ClinicalTrials.gov Identifier: NCT04571190
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Copenhagen University Hospital, Amager-Hvidovre, Denmark
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 18, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date April 30, 2021
Actual Study Start Date  ICMJE January 25, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
The Perceived Stress Scale [ Time Frame: From baseline to three-months follow-up ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • The Edinburgh Depression Scale [ Time Frame: From baseline to three-months follow-up ]
    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.
  • The Depression, Anxiety Stress Scales [ Time Frame: From baseline to three-months follow-up ]
    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.
  • WHO-5 [ Time Frame: From baseline to three-months follow-up ]
    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.
  • Prenatal Reflective functioning [ Time Frame: From baselineResponses are rated on a scale from 7 (strongly agree) to 1 (strongly disagree). to three-months follow-up ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2020)
  • The Experiences Questionnaire: subscale for decentering [ Time Frame: From baseline to three-months follow-up ]
    Decentering reflects the capacity to take a nonjudgmental and accepting stance regarding one´s thoughts and emotions as opposed to identifying with them. The decentering subscale of the experiences questionnaire consists of 11 items with a total score ranging from 11 - 55. Higher scores indicate higher decentering. Initial support has been found for reliability and validity of the scale as a measure of decentering.
  • The Five Facet Mindfulness Questionnaire [ Time Frame: From baseline to three-months follow-up ]
    The Five Facet Mindfulness Questionnaire (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). Each facet score range from 8 - 40 or from 7 - 35. Higher scores suggest higher levels of mindfulness.
  • Compassion [ Time Frame: From baseline to three-months follow-up ]
    The Self-Compassion Scale measures the ability to have a healthy stand towards oneself that does not involve evaluations of self-worth. The scale consists of 16 items and responses are given on a 5-point scale from 1 (almost never) to 5 (almost always). Higher scores indicate more self-compassions. The psychometric properties of the scale has been extensive evaluated.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Adapted Mindfulness-based Stress Reduction Program for High-risk Pregnancies
Official Title  ICMJE An Adapted Mindfulness-based Stress Reduction Program for High-risk Pregnancies - a Protocol for a Randomized Feasibility Study in a Danish Hospital-based Outpatient Setting
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description:
Group affiliation will be concealed for the researcher performing the statistical analyses. Participants will be informed that the overall purpose of the study is to examine the feasibility, acceptability and effect of prenatal MBSR and they are thus not blind to group allocation.
Primary Purpose: Prevention
Condition  ICMJE Pregnancy, High Risk
Intervention  ICMJE Behavioral: Prenatal MBSR
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.
Other Names:
  • Mindfulness-based stress reduction
  • MBSR
Study Arms  ICMJE
  • Experimental: Prenatal MBSR
    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.
    Intervention: Behavioral: Prenatal MBSR
  • No Intervention: Usual care
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sine S Skovbjerg, PhD 26357227 ext 45 sine.skovbjerg@clin.au.dk
Contact: Lone Fjorback, PhD lone.overby.fjorback@clin.au.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04571190
Other Study ID Numbers  ICMJE 07121971
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Copenhagen University Hospital, Amager-Hvidovre, Denmark
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP