Psychobiological Interventions in Pregnancy

NCT06430853 | Enrolling By Invitation FDA Device

• 2 other identifiers: IRB-747411K23HD113845
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications; Mental Health Issue; Depression, Anxiety; Pregnancy, High Risk; Biological Clock Disturbance

Keywords

Pregnancy; Stress; Mental health; Depression; Anxiety; Telomeres; Cortisol; Physical activity; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in EPDS Anxiety Subscale Score

  Randomization around 20 weeks gestation and end of study (around 37 weeks)

• Change in State-Trait Anxiety Inventory (STAI) Score

  Randomization around 20 weeks gestation and end of study (around 37 weeks)

• Change in leukocyte telomere length

  Randomization around 20 weeks and end of study (around 37 weeks)

• Change in hair cortisol level

  Randomization around 20 weeks and end of study (around 37 weeks)

• Frequency of pregnancy complications

  6 weeks postpartum

Study Arms (2)

Usual step count

PLACEBO COMPARATOR

Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 36 weeks of gestation.

Device: Actigraph watch

Step count goal

EXPERIMENTAL

Participants will be given a daily step count goal of 8,000 steps per day based on the Actigraph watch, between 20 and 36 weeks of gestation. If they are not at goal, a step-up protocol will be designed for each participant and reviewed with a study team member every 2 weeks.

Behavioral: Step count goal; Device: Actigraph watch

Interventions

Step count goal BEHAVIORAL

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 weekly reminders that are tailored for their intervention arm. Intervention group participants will also receive a step count diary with motivational ideas of how to obtain step goals, which will be reviewed with a study team member every 2 weeks.

Step count goal

Actigraph watch DEVICE

Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.

Also known as: Actigraph GT9X Link Accelerometer

Step count goal; Usual step count

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Depression; Anxiety Disorders; Chronobiology Disorders; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Nervous System Diseases; Personal Satisfaction

Study Officials

• Danielle M Panelli, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)