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Behavioral Intervention

Exercise for Depression and Anxiety During Pregnancy (PIP Trial)

N/A
Waitlist Available
Led By Danielle M Panelli, MD, MS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting for a prenatal visit with a viable singleton gestation between 18 and 20 weeks 0 days (no known lethal fetal anomaly or plan for pregnancy termination)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization around 20 weeks and end of study (around 37 weeks)
Awards & highlights

Summary

This trial will see if exercise can help improve mental health and reduce stress in pregnant women with depression or anxiety. Participants will be enrolled if they are receiving prenatal care at Stanford Children's Health Obstetrics Clinic

Who is the study for?
This trial is for pregnant individuals with symptoms of depression or anxiety who are receiving prenatal care at Stanford Children's Health Obstetrics Clinic and have a single pregnancy. Details on who can't join are not provided.
What is being tested?
The study tests if wearing an Actigraph watch and following a step count goal can improve mental health and reduce stress markers in pregnant people with mood disorders.
What are the potential side effects?
Since the interventions involve non-invasive monitoring and physical activity, side effects may include typical exercise-related issues such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant with one baby, between 18-20 weeks, with no known severe fetal issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization around 20 weeks and end of study (around 37 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization around 20 weeks and end of study (around 37 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Edinburgh Postpartum Depression Scale (EPDS) Score
Secondary outcome measures
Change in EPDS Anxiety Subscale Score
Change in State-Trait Anxiety Inventory (STAI) Score
Change in hair cortisol level
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Step count goalExperimental Treatment2 Interventions
Participants will be given a daily step count goal of 9,000 steps per day based on the Actigraph watch, between 20 and 37 weeks of gestation. They will receive monthly text reminders reminding them of the step count goal and offering ways to achieve this goal.
Group II: Usual step countPlacebo Group1 Intervention
Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 37 weeks of gestation. They will receive monthly text reminders to wear their watch as much as possible.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,851 Total Patients Enrolled
5 Trials studying Pregnancy Complications
212 Patients Enrolled for Pregnancy Complications
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,435 Total Patients Enrolled
8 Trials studying Pregnancy Complications
44,558 Patients Enrolled for Pregnancy Complications
Danielle M Panelli, MD, MSPrincipal InvestigatorStanford University
~59 spots leftby Jan 2027
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