CompletedNot Applicable

Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum

United States84 participantsStarted 2023-09-01

Plain-language summary

The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pregnancy between 12 and 30 weeks gestation * reporting at least mild psychological distress (based on self-report) * access to high-speed internet or cellular network access * located in the U.S. Exclusion Criteria: * current suicidal or homicidal ideation as assessed verbally during screening * symptom severity necessitating a higher level of clinical care * current psychosis * untreated mania * active substance abuse * lack of high-speed internet connection or cellular network access * planning to be traveling without access to internet for more than two weeks in the next 12 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in presence and severity of depressive symptoms from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in presence and severity of depressive symptoms from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in perceptions of daily life stress from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in perceptions of daily life stress from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in anxiety symptoms from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in anxiety symptoms from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in rumination from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Trial details

NCT IDNCT05137925

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Psychological Distress trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in presence and severity of depressive symptoms from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in presence and severity of depressive symptoms from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in perceptions of daily life stress from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in perceptions of daily life stress from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in anxiety symptoms from baseline to 8 weeks

Timeframe: baseline and 8 weeks

Change in anxiety symptoms from 8 weeks to 3 months

Timeframe: 8 weeks and 3 months

Change in rumination from baseline to 8 weeks

Timeframe: baseline and 8 weeks