Exercise for Depression and Anxiety During Pregnancy

(PIP Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cardiovascular condition, Bipolar, Schizophrenia, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether regular physical activity can improve mental health in pregnant individuals with symptoms of depression or anxiety. Participants will divide into two groups: one group will aim to walk 8,000 steps a day, while the other will track their steps without a specific goal. It suits those pregnant with one baby, receiving prenatal care, and experiencing a history or current signs of depression or anxiety. The trial seeks to determine if increased movement can reduce stress and improve mood during pregnancy. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes can enhance mental well-being during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this physical activity intervention is safe for pregnant individuals?

Research shows that exercising during pregnancy is usually safe and well-tolerated. Studies have found that exercise can boost mood and lower the risk of depression and anxiety. For example, one review found that high levels of physical activity reduced the chances of developing depression by about 32% and anxiety by about 33%. No evidence suggests harm to the pregnancy when exercise is done safely and there are no medical reasons to avoid it. In fact, exercise during pregnancy is linked to better overall outcomes. Regular physical activity, such as aiming for a step count goal, is considered safe for most pregnant individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for depression and anxiety during pregnancy because it offers a natural and accessible approach compared to traditional medications and therapies. Unlike antidepressants or therapy sessions that can be costly and have potential side effects, this physical activity intervention encourages expectant mothers to reach a daily step count goal, promoting overall well-being without medication. By personalizing the step goals and providing regular support, this method empowers pregnant women to take an active role in their mental health, potentially offering a safe and effective alternative to manage symptoms during pregnancy.

What evidence suggests that this physical activity intervention is effective for improving mental health in pregnant people with depression or anxiety?

Research shows that exercise can significantly reduce depression symptoms in pregnant women. In this trial, one group of participants will aim for a daily step count of 8,000 steps to encourage physical activity. Studies have found that staying active during pregnancy lowers the risk of postpartum depression. Moderate exercise is especially beneficial for the mental health of expecting mothers. Overall, exercising during pregnancy is safe and offers many benefits. ^{2 4 5 6 7}

Who Is on the Research Team?

Danielle M Panelli, MD, MS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am pregnant with one baby, between 18-20 weeks, with no known severe fetal issues.

Able to read and write in English or Spanish

I have a history of depression or anxiety in the last 2 years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a physical activity intervention with a step count goal or usual step count monitoring from 20 to 36 weeks of gestation

16 weeks

Bi-weekly reviews with study team

Follow-up

Participants are monitored for mental health and biological markers of stress, as well as pregnancy and neonatal complications

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Step count goal Experimental Treatment 2 Interventions

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.

Group II: Usual step count Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11456520/

The effects of exercise on antenatal depression

The results indicate that exercise interventions significantly contribute to the improvement of antenatal depressive symptoms in pregnant women.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032722012174

The impact of physical activity intervention on perinatal ...

In pregnant women, moderate-intensity physical activity has been shown to decrease the risk of postpartum depression (Dipietro et al., 2019).

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36796860/

Effectiveness of physical activity interventions for improving ...

The largest benefits were seen in people with depression, HIV and kidney disease, in pregnant and postpartum women, and in healthy individuals.

4.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-19564-w

Effect of different physical activity interventions on perinatal ...

The results indicate that relaxation therapy has the most effective outcome in reducing perinatal depression (SUCRA = 99.4%). Following that is ...

5.

acog.org

acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/04/physical-activity-and-exercise-during-pregnancy-and-the-postpartum-period

Physical Activity and Exercise During Pregnancy and the ...

Physical activity and exercise in pregnancy are associated with minimal risks and have been shown to benefit most women.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9772147/

Physical activity and pregnancy outcomes: An expert review

At 16 weeks of gestation, individuals who reported greater overall physical fitness displayed fewer depressive symptoms (ß=0.20, p=0.035) and ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032722004876

A systematic review and meta-analysis of observational ...

High levels of physical activity during pregnancy decreased the odds of developing prenatal depression and anxiety by 32% and 33%, ...