Psychobiological Interventions in Pregnancy

Mental Health Issue Clinical Trial

— PIP  

Official title:

Psychobiological Effects of Lifestyle Interventions in Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430853
• Other study ID #: IRB-74741
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Chronobiology Disorders
• Depression
• Depression, Anxiety
• Mental Health Issue
• Pregnancy Complications
• Pregnancy, High Risk

Intervention

Behavioral:
• Step count goal
The step count goal will be discussed at the beginning of the study, and participants will be able to see their step count on the Actigraph watch to facilitate achieving this goal. All participants will receive monthly reminders that are tailored for their intervention arm.

Device:
• Actigraph watch
Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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