Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial

Autor: Lianne P Hulsbosch, Victor J M Pop, Ivan Nyklíček, Margreet Meems, Eva S. Potharst, Myrthe G. B. M. Boekhorst
Přispěvatelé: Medical and Clinical Psychology, Developmental Psychopathology (RICDE, FMG)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
050103 clinical psychology
Mindfulness
Psychological intervention
Anxiety
Online intervention
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Pregnancy
Surveys and Questionnaires
Medicine
Netherlands
Randomized Controlled Trials as Topic
ASSOCIATIONS
Depression
05 social sciences
Obstetrics and Gynecology
Distress
Treatment Outcome
DEPRESSIVE SYMPTOMS
Female
medicine.symptom
MENTAL-HEALTH
STRESS REDUCTION
medicine.medical_specialty
QUESTIONNAIRE
lcsh:Gynecology and obstetrics
03 medical and health sciences
Intervention (counseling)
Humans
0501 psychology and cognitive sciences
FACETS
METAANALYSIS
lcsh:RG1-991
business.industry
Repeated measures design
COGNITIVE THERAPY
medicine.disease
030227 psychiatry
Pregnancy Complications
PSYCHOMETRIC PROPERTIES
Pregnancy distress
Rumination
Physical therapy
business
Stress
Psychological
Zdroj: BMC Pregnancy and Childbirth, Vol 20, Iss 1, Pp 1-10 (2020)
BMC Pregnancy and Childbirth, 20(1):159. BioMed Central
BMC Pregnancy and Childbirth
BMC Pregnancy and Childbirth, 20:159. BioMed Central
ISSN: 1471-2393
Popis: Background Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. Methods The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12 weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. Discussion The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms. Trial registration ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.
Databáze: OpenAIRE
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