An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.
NCT ID: NCT04571190
Last Updated: 2022-05-31
Study Results
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Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2021-01-25
2022-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* schizophrenia, psychosis, PTSD, schizotypal personality disorder or other major psychiatric disorder
* suicidality
18 Years
FEMALE
No
Sponsors
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Copenhagen University Hospital, Hvidovre
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Capital Region, Denmark
Countries
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References
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Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
Wielgosz J, Goldberg SB, Kral TRA, Dunne JD, Davidson RJ. Mindfulness Meditation and Psychopathology. Annu Rev Clin Psychol. 2019 May 7;15:285-316. doi: 10.1146/annurev-clinpsy-021815-093423. Epub 2018 Dec 10.
Crane RS, Brewer J, Feldman C, Kabat-Zinn J, Santorelli S, Williams JM, Kuyken W. What defines mindfulness-based programs? The warp and the weft. Psychol Med. 2017 Apr;47(6):990-999. doi: 10.1017/S0033291716003317. Epub 2016 Dec 29.
Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.
Dhillon A, Sparkes E, Duarte RV. Mindfulness-Based Interventions During Pregnancy: a Systematic Review and Meta-analysis. Mindfulness (N Y). 2017;8(6):1421-1437. doi: 10.1007/s12671-017-0726-x. Epub 2017 Apr 17.
Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
Luyten P, Fonagy P. The neurobiology of mentalizing. Personal Disord. 2015 Oct;6(4):366-79. doi: 10.1037/per0000117.
Pajulo M, Tolvanen M, Karlsson L, Halme-Chowdhury E, Ost C, Luyten P, Mayes L, Karlsson H. THE PRENATAL PARENTAL REFLECTIVE FUNCTIONING QUESTIONNAIRE: EXPLORING FACTOR STRUCTURE AND CONSTRUCT VALIDITY OF A NEW MEASURE IN THE FINN BRAIN BIRTH COHORT PILOT STUDY. Infant Ment Health J. 2015 Jul-Aug;36(4):399-414. doi: 10.1002/imhj.21523. Epub 2015 Jun 19.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Smith-Nielsen J, Matthey S, Lange T, Vaever MS. Validation of the Edinburgh Postnatal Depression Scale against both DSM-5 and ICD-10 diagnostic criteria for depression. BMC Psychiatry. 2018 Dec 20;18(1):393. doi: 10.1186/s12888-018-1965-7.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Lee D. The convergent, discriminant, and nomological validity of the Depression Anxiety Stress Scales-21 (DASS-21). J Affect Disord. 2019 Dec 1;259:136-142. doi: 10.1016/j.jad.2019.06.036. Epub 2019 Jun 30.
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
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.
Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.
Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
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.
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.
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.
Other Identifiers
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07121971
Identifier Type: -
Identifier Source: org_study_id
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