Recruiting

Mindfulness Training

Sponsor:

Medical College of Wisconsin

Code:

NCT07218237

Conditions

Preeclampsia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness training

Garmin Vivoactive 4 watch

Study Details

Brief summary:

The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.

Conditions

Preeclampsia

Study ID

NCT07218237

Start date

Apr 28, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant patients at gestational age <= 16 weeks
  • Live, non-anomalous gestation
  • Normotensive at enrollment
  • Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG/USPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy

Exclusion Criteria:

  • Multiple gestation
  • Chronic (pregestational hypertension)
  • Inability of unwillingness to provide informed consent
  • Active suicidality or psychosis
  • Ongoing mind-body practice (e.g., yoga, meditation, mindfulness >= once per week)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MT + Biofeedback

Mindfulness training plus self-monitoring with access to data from wearable biosensor

experimental: MT

Mindfulness training (no access to wearable biosensor data)

no intervention: Control

Routine prenatal care alone

Interventions

Mindfulness training

Mindfulness training with trained instructors

Garmin Vivoactive 4 watch

Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

Primary outcome measure

  • Feasibility of multisite RCT [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Anna Palatnik, MD

14148056627apalatnik@mcw.edu

Alyssa Hernandez, DO

4149552781alyhernandez@mcw.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Margaret Bublitz, PhD

401-793-7884mbublitz@brownhealth.org

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Anna Palatnik, MD

14148056627apalatnik@mcw.edu

Alyssa Hernandez, DO

4149552781alyhernandez@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Hypertensive disorders of pregnancy
  • Mindfulness
  • Biofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-20.