Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402604
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2023-05-09
Brief Title:
Stress Reduction in Formerly Preeclamptic Women Sofa or Sports
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Stress Reduction in Formerly Preeclamptic Women Sofa or Sports
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOS
Brief Summary:
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history The main questions it aims to answer are
to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia
to examine the effects of mindfullness based stress reduction MBSR or aerobic exercise training on hair cortisol and symptoms of mental stress
Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments head tilt test and give a hair sample As intervention they will sport or do mindfulness for 3 monthsThey will be compared with a control group
to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia
to examine the effects of mindfullness based stress reduction MBSR or aerobic exercise training on hair cortisol and symptoms of mental stress
Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments head tilt test and give a hair sample As intervention they will sport or do mindfulness for 3 monthsThey will be compared with a control group
Detailed Description:
Rationale Approximately one out of three women with pre-term preeclampsia develops a post-traumatic stress disorder or depression after pregnancy This could be related to the psychological impact of preeclampsia and premature birth resulting in increased perceived stress It is also possible that preeclampsia and stress levels share a common aetiology as both appear to correlate with increased cortisol levels and higher sympathetic drive Approximately 50 of women with a history of preeclampsia have low plasma volume levels indicating reduced circulatory reserve Women with a hemodynamic profile characterized by a limited circulatory reserve have increased resting sympathetic tone and are prone to develop preeclampsia in a subsequent pregnancy These women also report more complaints of perceived stress This raises not only the question whether increased perceived stress in women with a history of preeclampsia originates within the brain itself primary psychological or whether it is a psychological reflection of underlying reduced circulatory reserves secondary psychological but also the question about which intervention is most effective to reduce this perceived stress level Should the investigators focus more on the emotional coping mechanisms and psychological aspects or should the investigators aim at improving the underlying hemodynamic profile and circulatory reserves to reduce overall sympathetic drive The investigators hypothesize that 1 both interventions in women with preeclampsia and increased mental stress complaints will result in improved circulatory reserve lower cortisol levels lower sympathetic resting tone and better continuous physiological measures as measured with a smartwatch during the trial 2 The aerobic exercise training will additionally improve the womens cardiovascular risk profile
Objective To investigate the effects of online mindfulness-based stress reduction MBSR therapy and aerobe exercise training on mental stress physiological stress hair cortisol and cardiovascular risk profile in women with a history of preeclampsia and current increased symptoms of mental stress
Study design Multicenter randomized trial of two interventions online mindfulness therapy and aerobic exercise training and a time control group who undergo neither of the two interventions wait list group Possible eligible women will be recruited in two tertiary hospitals Radboudumc Nijmegen and Maastricht Medical Centre after referral to these centres for preconceptional cardiovascular assessment after severe preeclampsia in a previous pregnancy Participants with symptoms of mental stress will be randomly assigned to either one of the two intervention groups or the wait list 3 options after the Preconceptional Cardiovascular Assessment PcCA and Stress Assessment SA After 12 weeks of intervention or in the case of the wait list group 12 weeks without intervention another PcCA and SA will take place Results after 12 weeks will be compared with baseline results Additionally in all groups online questionnaires will be filled in 6 months after baseline assessments Women who were allocated to the wait list group are offered either mindfulness therapy or aerobic exercise training after completing the second PcCA and SA after 12 weeks
Study population Primiparous women with an obstetric history of preeclampsia according to ISSHP definition who score 16 on the Perceived Stress Scale PSS 41 on the State-Trait Anxiety Inventory STAI or 10 on the Edinburgh Postnatal Depression Scale EPDS during online questionnaires as part of the anamnesis of PcCA will be prompted to join the study Women with pre-existent diabetes mellitus autoimmune disease overt cardiovascular disease or use of tabacco or medication that might affect the cardiovascular system are excluded from participation Other exclusion criteria are plans to become pregnant within the time frame of the intervention 12 weeks at time of baseline assessment
Intervention One group receives a 12-weeks standard online MBSR therapy consisting of 8 weekly group meetings one day silent retreat and daily homework A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80 individual heart rate reserve HRR for 2 to 3 times per week Finally the time control wait list group will be asked to continue normal activities and lifestyle and wont undergo guided mindfulness therapy or exercise training during the 12 weeks study period
Main study parameters The primary endpoint is mental stress evaluated with validated questionnaires PSS STAI and EPDS Secondary endpoints are the results of pre- and post-intervention pre-conceptional standard cardiovascular assessments These cardiovascular assessments are in Maastricht UMC tertiary hospital care as usual after referral for preconceptional evaluation in women with a history of preeclampsia This assessment includes biometrics 30-minutes blood pressure and heart rate measurement venous blood samples for metabolic syndrome screening echocardiography and plasma volume assessment For this specific study the investigators will additionally assess cortisol concentration in hair and evaluate sympathetic activity during a head-up tilt test using non-invasive heart rate variability analysis During the exercise training heartbeat monitoring will be measured using smartwatches Feasibility of the interventions will be evaluate with additional participant survey at follow-up measurement
Objective To investigate the effects of online mindfulness-based stress reduction MBSR therapy and aerobe exercise training on mental stress physiological stress hair cortisol and cardiovascular risk profile in women with a history of preeclampsia and current increased symptoms of mental stress
Study design Multicenter randomized trial of two interventions online mindfulness therapy and aerobic exercise training and a time control group who undergo neither of the two interventions wait list group Possible eligible women will be recruited in two tertiary hospitals Radboudumc Nijmegen and Maastricht Medical Centre after referral to these centres for preconceptional cardiovascular assessment after severe preeclampsia in a previous pregnancy Participants with symptoms of mental stress will be randomly assigned to either one of the two intervention groups or the wait list 3 options after the Preconceptional Cardiovascular Assessment PcCA and Stress Assessment SA After 12 weeks of intervention or in the case of the wait list group 12 weeks without intervention another PcCA and SA will take place Results after 12 weeks will be compared with baseline results Additionally in all groups online questionnaires will be filled in 6 months after baseline assessments Women who were allocated to the wait list group are offered either mindfulness therapy or aerobic exercise training after completing the second PcCA and SA after 12 weeks
Study population Primiparous women with an obstetric history of preeclampsia according to ISSHP definition who score 16 on the Perceived Stress Scale PSS 41 on the State-Trait Anxiety Inventory STAI or 10 on the Edinburgh Postnatal Depression Scale EPDS during online questionnaires as part of the anamnesis of PcCA will be prompted to join the study Women with pre-existent diabetes mellitus autoimmune disease overt cardiovascular disease or use of tabacco or medication that might affect the cardiovascular system are excluded from participation Other exclusion criteria are plans to become pregnant within the time frame of the intervention 12 weeks at time of baseline assessment
Intervention One group receives a 12-weeks standard online MBSR therapy consisting of 8 weekly group meetings one day silent retreat and daily homework A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80 individual heart rate reserve HRR for 2 to 3 times per week Finally the time control wait list group will be asked to continue normal activities and lifestyle and wont undergo guided mindfulness therapy or exercise training during the 12 weeks study period
Main study parameters The primary endpoint is mental stress evaluated with validated questionnaires PSS STAI and EPDS Secondary endpoints are the results of pre- and post-intervention pre-conceptional standard cardiovascular assessments These cardiovascular assessments are in Maastricht UMC tertiary hospital care as usual after referral for preconceptional evaluation in women with a history of preeclampsia This assessment includes biometrics 30-minutes blood pressure and heart rate measurement venous blood samples for metabolic syndrome screening echocardiography and plasma volume assessment For this specific study the investigators will additionally assess cortisol concentration in hair and evaluate sympathetic activity during a head-up tilt test using non-invasive heart rate variability analysis During the exercise training heartbeat monitoring will be measured using smartwatches Feasibility of the interventions will be evaluate with additional participant survey at follow-up measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None