Mindfulness Based Cognitive Therapy for Infant Development

Phase-Based Estimates
1
Effectiveness
1
Safety
Oregon Health and Science University, Portland, OR
+4 More
Mindfulness Based Cognitive Therapy - Behavioral
Eligibility
< 65
Female
Eligible conditions
Infant Development

Study Summary

This study is evaluating whether mindfulness based cognitive therapy may help reduce stress in pregnant women.

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Eligible Conditions

  • Infant Development
  • Prenatal Stress
  • Functional Neuroimaging
  • Maternal Psychological Distress
  • Pregnancy Related

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Mindfulness Based Cognitive Therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Infant Development. Measurement will happen over the course of Infant Scan (T6).

34 Weeks GA (T5)
Blood assay for inflammatory marker IL6
Maternal Cortisol
Infant Scan (T6)
Neonatal Resting State fMRI scan
Neonatal Structural MRI scan
Week 34
Maternal Psychological Stress
Week 34
Maternal Pregnancy Specific Psychological Stress

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Mindfulness Based Cognitive Therapy

This trial requires 172 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mindfulness Based Cognitive Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mindfulness Based Cognitive Therapy
Behavioral
MBCT adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. The intervention is focused on skill development through active engagement in mindfulness practices and exercises to increase awareness of thoughts, feelings and behavior in session, and assignment and review of daily home practices.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Cognitive Therapy
2014
Completed Phase 4
~1550

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 34 weeks ga (t5)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 34 weeks ga (t5) for reporting.

Who is running the study

Principal Investigator
A. G.
Alice Graham, MD
Oregon Health and Science University

Closest Location

Oregon Health and Science University - Portland, OR

Eligibility Criteria

This trial is for female patients aged 65 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Inclusion

Patient Q&A Section

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

How many people get pregnancy related a year in the United States?

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About 830,000 US women are pregnant a year in the US. Women of the United States bear nearly one-third of all U.S. births and contribute the largest number of all births, representing 20% of all U.S births.

Unverified Answer

What are common treatments for pregnancy related?

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Evidence-based treatment guidelines for pregnancy related are lacking. Although various types of medications are prescribed to patients with symptomatic pregnancies, a lack of evidence supporting medication use makes prescribing guidelines difficult.

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What causes pregnancy related?

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Many factors that contribute to pregnancy related include tobacco use, alcohol use, mental illness, obstetric history and history of diabetes. Those with a history of pregnancy complications are likely to have more adverse effects on the pregnancy, resulting in adverse consequences of the pregnancy.

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What are the signs of pregnancy related?

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Signs of labor are as follows: fetal heartbeat, rising and falling temperatures, and feeling a pressure or a sudden rush as you push.\n\nIf the fetus is not getting oxygen from mom, she may stop fetal heartbeat and start to turn into an inactive, not growing, or damaged fetus.\n\nTowards the end of pregnancy, the mother's heart rate may also speed or slow, depending on the amount of blood pumped out by the heart. This could be the first warning sign of a problem or complication associated with pregnancy. Sometimes the mother may feel a sudden surge of pressure or a sudden drop in pressure in her womb, or feel a sudden or sudden surge-quick in her uterus.

Unverified Answer

Can pregnancy related be cured?

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Pregnancy related CVS can be successfully treated by combining conservative measures such as anti-emetics and anti-inflammatory medications with appropriate and timely interventional management such as surgery and balloon dilatation. It will be an effective choice in the management of CVS when surgery and medical approach are not possible.

Unverified Answer

What is pregnancy related?

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There is a growing body of evidence that shows that the risk of obesity, insulin resistance and type 2 diabetes in adulthood is higher in women who have had a pregnancy at an early age. In a review of recent data, it seems reasonable to suggest that in the last decade, women who are pregnant or have had a baby by the age of 18 and 19 have experienced faster growth and increased body fat. The duration, number, and spacing of pregnancies, if not taken into consideration, may be important. Therefore, the timing of births may have impact on their offspring's chances of developing type 2 diabetes earlier in adulthood. In spite of many years of effort, to date, no effective prevention strategy has been developed. The underlying mechanisms remain not very clear.

Unverified Answer

How serious can pregnancy related be?

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When evaluating the correlation between pregnancy and other diseases in the family, serious disorders like cystic fibrosis, epilepsy or cancer may present with no symptoms in early adolescence. Thus, such evaluation should be made and discussed with the adolescents and parents.

Unverified Answer

What does mindfulness based cognitive therapy usually treat?

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The majority of patients were satisfied or very satisfied with the MBCT treatment provided after 12-week treatment. Cognitive therapy can be provided alone or in combination with psychological therapy. However, individualized treatment in the clinical practice is recommended with the provision of sufficient information and the support of professionals.

Unverified Answer

What is the primary cause of pregnancy related?

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There is only one common primary cause: smoking. Many pregnancies related to smoking were from women who did not intend to become pregnant and tried to stop when they realized they were pregnant. This might explain some of the fetal losses associated with heavy smoking during pregnancy.

Unverified Answer

Is mindfulness based cognitive therapy typically used in combination with any other treatments?

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Despite the lack of evidence for an additional benefit of adding MBCT to a well-established treatment, a subset from this meta-analysis seems to be beneficial. Based on the results of this study, additional randomized controlled trials with a large sample size are needed to conclude that MBCT as an adjunct to current evidence-based treatments is effective.

Unverified Answer

Does pregnancy related run in families?

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In a recent study, findings of this population-based (inclusive of families of all races and ethnic groups) analysis of 527 cases of diabetes mellitus-associated end-organ disease and a control group of 909 non-familial patients suggest that there are significant familial patterns in the incidence and timing in the development of some manifestations of DME.

Unverified Answer

Does mindfulness based cognitive therapy improve quality of life for those with pregnancy related?

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The inclusion of a mindfulness component in treatment for women experiencing stress related to their pregnancy can improve both physical and mental health. The inclusion of a mindfulness component in rehabilitation can enhance the effect of rehabilitation programs in improving quality of life for women.

Unverified Answer
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