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

NCT04571190 | Completed DMC

• 1 other identifier: 07121971
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, High Risk

Keywords

Prenatal mental health; Pregnancy, High Risk; Mindfulness; Mindfulness-based stress reduction; MBSR; Prenatal mindfulness-based stress reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Edinburgh Depression Scale

  From baseline to three-months follow-up

• The Depression, Anxiety Stress Scales

  From baseline to three-months follow-up

• WHO-5

  From baseline to three-months follow-up

• Prenatal Reflective functioning

  From baselineResponses are rated on a scale from 7 (strongly agree) to 1 (strongly disagree). to three-months follow-up

Other Outcomes (3)

• The Experiences Questionnaire: subscale for decentering

  From baseline to three-months follow-up

• The Five Facet Mindfulness Questionnaire

  From baseline to three-months follow-up

• Compassion

  From baseline to three-months follow-up

Study Arms (2)

Prenatal MBSR

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Prenatal MBSR BEHAVIORAL

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.

Also known as: Mindfulness-based stress reduction, MBSR

Prenatal MBSR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Due date no sooner than three months from start of the mindfulness program
• able to speak and write Danish
• written informed consent to study criteria

You may not qualify if:

• concurrent substance abuse
• schizophrenia, psychosis, PTSD, schizotypal personality disorder or other major psychiatric disorder
• suicidality

Sponsors & Collaborators

• University of Aarhus: lead
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (1)

Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Capital Region, 2650, Denmark

Location

Related Publications (22)

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• Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.

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• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

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• Skovbjerg S, Kolls M, Kjaerbye-Thygesen A, Fjorback LO. Mindfulness-Based Stress Reduction adapted to pregnant women with psychosocial vulnerabilities - a randomized feasibility trial in a Danish hospital-based outpatient setting. Pilot Feasibility Stud. 2025 Jun 21;11(1):86. doi: 10.1186/s40814-025-01670-0.

  PMID: 40544301 DERIVED

• Skovbjerg S, Birk D, Bruggisser S, Wolf ALA, Fjorback L. Mindfulness-based stress reduction adapted to pregnant women with psychosocial vulnerabilities-a protocol for a randomized feasibility study in a Danish hospital-based outpatient setting. Pilot Feasibility Stud. 2021 Jun 3;7(1):118. doi: 10.1186/s40814-021-00860-w.

  PMID: 34082839 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 30, 2020
• Study Start: January 25, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 31, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)