To investigate whether online mindfulness-based stress reduction (MBSR) therapy and an aerobe training intervention both leading to stress reduction and reduced circulatory risk in formerly preeclamptic women with increased mental stress levels…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is mental stress, measured by validated questionnaires about
anxiety, perceived stress and symptoms of depression.
Secondary outcome
Secondary endpoints are the results of pre- and post-intervention
pre-conceptionally cardiovascular assessments, which with take place as *care-
as-usual*. These measures include: body surface area, 30-minutes blood pressure
and heart rate measures, venous blood samples for metabolic syndrome,
echocardiography and plasma volume. Additionally, cortisol concentration in
hair and head-up tilt test are analyzed. During intervention period, daily life
stress and heartbeat monitoring with be measured through continious
physiological recordings using smartwatches and will be analyzed to monitor
compliance to intervention and examine the relationship between daily life
functioning clinical efficacy of MBSR or aerobe cycling training. Results of
validated questionnaires STAI, EPDS and Symptom-Checklist-90 (SCL-90) 12 weeks
after intervention will be used as follow-up.
Background summary
Approximately one out of three women with pre-term pre-eclampsia (PE) develops
a post-traumatic stress disorder or depression after labour. This could related
to the psychological impact of PE and premature birth. It could also be
possible that stress correlates with reduced circulatory reserves, which is
more indicative of physiological dysfunction. Limited circulatory reserves are
also associated with basal increased sympathetic tone, decreased orthostatic
stress response capacity and the later development of PE. These women report
more complaints of perceived stress. This raises the question whether increased
stress originates in the psyche or whether it is a psychological reflection of
underlying reduced circulatory reserves and which intervention is needed to
reduce stress. We hypotheze that women with reduced plasma volume status have
higher levels of cortisol and mental stress, and therefore both aerobe training
and mindfulness-based stress reduction are effective to reduce stress and
cortisol levels, leading to decreased circulatory risk calculation.
Study objective
To investigate whether online mindfulness-based stress reduction (MBSR) therapy
and an aerobe training intervention both leading to stress reduction and
reduced circulatory risk in formerly preeclamptic women with increased mental
stress levels determined by the questionnaire
Study design
This will be a multicenter randomized controlled trial, lasting for
approximately 1 year. Recruitment will take place in a group of women with
severe preeclampsia in a previous pregnancy, and wishing to conceive, that are
referred by their healthcare professional to the extant pre-conceptionally
cardiovascular evaluation (Obstetrics department, Maastricht University Medical
Center). Participants will be randomised into a treatment or wait-list group
after baseline Pre-conceptionally Cardiovascular Assessment (PcCA) and Stress
Assessment (SA). Another SA and will take place post-treatment, combined with
regular scheduled re-assessment of PcCA. Approximately 24 months after baseline
online validated questionnaires about mental stress will be used as follow-up
measure.
Intervention
One group receives a 12-weeks during online MBSR therapy, consisting of 8
weekly group meetings, one day silent retreat, and daily homework. The other
group attend a aerobe training program, consists of 12-weeks of HR-controlled
training on a cycle trainer at 70-80% individual HR reserve (HRR) for 2 to 3
times per week. A third control group on waiting list for therapy will be asked
to continue normal physical activities and not undertake MBSR therapy during
study period.
Study burden and risks
Most outcomes were measured in all patients as part of *care-as-usual*
preconceptionally cardiovascular assessment appointments with two times an
addition of a stress assessment, including donating a sample of hair, a head-up
tilt (HUT) and a couple of questionnaires about basic characteristics. The hair
sample is cut near the scalp on the back of the head, without leaving a visible
bald spot. The burden and risks associated with participation are therefore
minimal and approved by the local ethical committee of Maastricht UMC+
registered under number 14-4-118. The 12-weeks aerobe cycling training program
could be physical and physiological intense and take a large time investment,
but is a normal and save training procedure. Previous study with this aerobe
training protocol used HUT as outcome measure. The risks of this minimal
invasive diagnostic test are low and the burden minor and combined with
training approved earlier by ethical committees and registered under CMO number
2008-226 (id: NCT00900458). Online MBSR therapy was performed and approved in a
previous RCT and registered under CMO number 2020-6682 (NL-nr: 74345.091.20).
The validated follow-up questionnaires will be performed online and takes 40
minutes to complete.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Informed consent given
- Age * 18 years
- Good understanding of Dutch language
- Preeclampsia in prior pregnancy, defined as the combination of gestational
hypertension (>=140/90mmHg, measured twice, six hours or more apart), and
proteinuria (consistently >=300mg/24 hours) after 20 weeks of pregnancy in
previously normotensive women, according to ISSHP definition (Brown, 2018).
- Normotensive at the time of baseline measurements
- Perceived Stress Scale score >= 16 or State-Trait Anxiety Inventory (STAI)
score >= 41 or Edinburgh Postnatal Depression Scale (EPDS) score >= 10
Exclusion criteria
- Pre-existent diabetes mellitus, autoimmune disease, HIV positivity or overt
cardio-vascular disease.
- Use of medication or supplements that might affect the cardiovascular system
- (Physical) inabilities to complete 12 weeks of moderate exercise training
- Currently involved in psychological therapy or MBSR training.
- Pregnancy
- Women who intend to become pregnant within 12 weeks after baseline assessment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00900458 |
| CCMO | NL78063.091.21 |