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Behavioral Intervention

Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy

N/A

Recruiting

Led By Michele Levine, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks to 3 months

Awards & highlights

Study Summary

This trial will help researchers understand how and why mindfulness-based cognitive therapy helps people during pregnancy, so that they can optimize treatment for psychological distress during this vulnerable period.

Who is the study for?

This trial is for pregnant individuals in the U.S. between 12 and 30 weeks along, experiencing mild psychological distress. They must have internet or cellular access. It's not for those with severe mental health issues like untreated mania, current psychosis, active substance abuse, or suicidal thoughts.Check my eligibility

What is being tested?

The study compares Mindfulness-Based Cognitive Therapy (MBCT) to usual treatment methods during pregnancy and postpartum to understand how MBCT improves well-being and manages psychological distress during these periods.See study design

What are the potential side effects?

Mindfulness-based therapies are generally considered safe but may bring up emotional discomfort as participants become more aware of their feelings. There are no known significant physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks to 3 months 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 anxiety symptoms from 8 weeks to 3 months

Change in anxiety symptoms from baseline to 8 weeks

Change in mindfulness from 8 weeks to 3 months

+8 more

Secondary outcome measures

Change in attention from 8 weeks to 3 months

Change in attention from baseline to 8 weeks

Change in cognitive inflexibility from 8 weeks to 3 months

+5 more

Other outcome measures

Engagement (attendance) at 8 weeks

Engagement (homework) at 8 weeks

Participant satisfaction at 3 months

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention

MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Cognitive Therapy (MBCT)

2014

N/A

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Pittsburgh FoundationOTHER

5 Previous Clinical Trials

279 Total Patients Enrolled

American Psychological FoundationOTHER

18 Previous Clinical Trials

1,857 Total Patients Enrolled

1 Trials studying Postpartum Depression

21 Patients Enrolled for Postpartum Depression

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,886 Total Patients Enrolled

1 Trials studying Postpartum Depression

8 Patients Enrolled for Postpartum Depression

Media Library

MBCT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05137925 — N/A

Postpartum Depression Research Study Groups: Mindfulness-Based Cognitive Therapy (MBCT), Treatment as Usual (TAU)

Postpartum Depression Clinical Trial 2023: MBCT Highlights & Side Effects. Trial Name: NCT05137925 — N/A

MBCT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05137925 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots available to participate in this research study?

"According to the records held on clinicaltrials.gov, this medical trial is still accepting participants for enrollment. It was initially posted in April 2022 and its details were recently updated at the beginning of July that same year."

Answered by AI

What is the total estimated number of participants for this clinical research?

"Affirmative. According to records on clinicaltrials.gov, this trial first appeared April 11th 2022 and was most recently updated July 11th 2022. Furthermore, the study is searching for 50 participants at a single location."

Answered by AI

What are the expected results of this clinical experiment?

"The primary aim of this clinical trial, which will be tracked from baseline up to 8 weeks, is to evaluate changes in perceptions of daily life stress. Secondary objectives include assessing variability in emotion regulation (using the 10-item Emotion Regulation Questionnaire), gauging disinhibited behaviour through a Go/No-Go task and measuring attention levels via the Stroop Color-Word Test over an interval spanning between 8 weeks and 3 months."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michele Levine 2023. "Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05137925.

All > Pregnancy