Psychobiological Interventions in Pregnancy

Launched by STANFORD UNIVERSITY · May 21, 2024

Keywords

ClinConnect Summary

Study Design This will be a randomized, parallel group, unblinded, single site superiority trial evaluating the impact of a physical activity intervention on reducing symptoms in people with known or screen-positivity for depression or anxiety during pregnancy. Participants will be randomized to a step count intervention versus usual care. Adherence will be monitored via Actigraph Link GT9X accelerometer watches.

Primary outcome: The primary outcome will be the mean within-person change in EPDS score between Time 2 (randomization) and Time 3 (37 weeks).

Secondary outcomes: Secondary outco...

Gender

FEMALE

Eligibility criteria

• 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)