Psychobiological Interventions in Pregnancy
Enrolling by invitation · Not applicable
Conditions studied: Pregnancy Complications, Mental Health Issue, Depression, Anxiety, Pregnancy, High Risk, Biological Clock Disturbance
In brief
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.
Key facts
- Study ID
- NCT06430853
- Run by
- Stanford University
- People needed
- 88
- Starts
- 2025-01-13
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Stanford University — Stanford, California, United States
Full record on ClinicalTrials.gov
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