Mental Health Issue Clinical Trial
— PIPOfficial title:
Psychobiological Effects of Lifestyle Interventions in Pregnancy
Verified date | May 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | January 2027 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Edinburgh Postpartum Depression Scale (EPDS) Score | The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of >=10 has been shown to be consistent with depressive symptoms. | Randomization around 20 weeks gestation and end of study (around 37 weeks gestation). | |
Secondary | Change in EPDS Anxiety Subscale Score | The mean within person change in Edinburgh Postpartum Depression Anxiety Subscale score between randomization and the end of the study will be compared between the 2 arms. The three-question anxiety subscale on the EPDS (EPDS 3A) has a score range between 0-9, and a score >=5 has been shown to be consistent with anxiety symptoms. | Randomization around 20 weeks gestation and end of study (around 37 weeks) | |
Secondary | Change in State-Trait Anxiety Inventory (STAI) Score | Mean within person change in STAI score between randomization and the end of the study will be compared between the 2 arms. The STAI is 40 questions, and the score ranges from 40 to 160. A STAI score >=80 has been shown to be consistent with anxiety symptoms. | Randomization around 20 weeks gestation and end of study (around 37 weeks) | |
Secondary | Change in leukocyte telomere length | Maternal leukocyte telomere length will be measured from saliva samples and analyzed via quantitative PCR. Mean within-person change in leukocyte telomere length will be compared between the two arms. | Randomization around 20 weeks and end of study (around 37 weeks) | |
Secondary | Change in hair cortisol level | Maternal hair cortisol level will be measured from consecutive segments of hair strands. Mean within-person change in hair cortisol level will be compared between the two arms. | Randomization around 20 weeks and end of study (around 37 weeks) | |
Secondary | Frequency of pregnancy complications | Frequency of pregnancy complications including hypertensive disorders, diabetes, fetal growth restriction, placental abruption, preterm birth, or stillbirth will be abstracted from the medical record | 6 weeks postpartum | |
Secondary | Frequency of neonatal complications | Frequency of neonatal complications including NICU admission, 5-minute Apgar <7, low birthweight, need for mechanical ventilation, or neonatal demise will be abstracted from the medical record | 6 weeks postpartum |
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