Psychobiological Interventions in Pregnancy (NCT06430853) | Clinical Trial Compass
By InvitationNot Applicable
Psychobiological Interventions in Pregnancy
United States88 participantsStarted 2025-01-13
Plain-language summary
This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to read and write in English or Spanish
* Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days
* Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5
Exclusion Criteria:
* Known allergy to steel or rubber
* Implantable medical device
* Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia
* Plan to relocate and/or deliver at another institution
* Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia)
* Known lethal fetal anomaly or nonviable pregnancy
* Baseline \>30 min per week of vigorous physical activity (from Pregnancy Physical Activity Questionnaire, PPAQ)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Edinburgh Postpartum Depression Scale (EPDS) Score
Timeframe: Randomization around 20 weeks gestation and end of study (around 37 weeks gestation).