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

88 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Physical Activity Intervention for depression and anxiety during pregnancy?

Research shows that exercise during pregnancy can reduce symptoms of depression and anxiety. Studies found that women who engaged in aerobic exercise or reported higher physical fitness experienced fewer depressive symptoms and lower anxiety levels. ^{1 2 3 4 5}

Is exercise safe for pregnant women with depression or anxiety?

Research shows that exercise during pregnancy is generally safe and can help reduce symptoms of depression and anxiety. Studies have found that physical activity can improve mental health and well-being for pregnant women. ^{1 2 3 5 6}

How does the physical activity intervention treatment for depression and anxiety during pregnancy differ from other treatments?

The physical activity intervention for depression and anxiety during pregnancy is unique because it involves supervised exercise sessions, which are non-pharmacological and avoid potential side effects of medications on the mother and fetus. This approach not only reduces depressive symptoms but also improves overall well-being, making it a safer alternative for pregnant women compared to traditional drug treatments. ^{1 2 3 7 8}

What is the purpose of this trial?

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.

Research Team

Danielle M Panelli, MD, MS

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Experiences of participation in supervised group exercise among pregnant women with depression or low psychological well-being: A qualitative descriptive study. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Impact of prenatal exercise on both prenatal and postnatal anxiety and depressive symptoms: a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity and mood during pregnancy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The favourable association of self-reported physical fitness with depression and anxiety during pregnancy. The GESTAFIT project. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prenatal Anxiety and Exercise. Systematic Review and Meta-Analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise during pregnancy attenuates prenatal depression: a randomized controlled trial. [2016]

8. Austria pubmed.ncbi.nlm.nih.gov

Exercise and yoga during pregnancy and their impact on depression: a systematic literature review. [2022]