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New treatment option for Mental Health Wellness 1
Official title Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
ClinicalTrials.gov ID: NCT05012072
What this study is testing
- What it's testing
- This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Providing informed consent;
- Ability to read and speak English
- Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound...
- Self-identification as African American or Hispanics
- Age 18 to 45 years
You likely can't join if
- After initial review of the electronic health record (EHR):
- Major systemic infections such as HIV, hepatitis
- \ 45 years of age
- Enrollment in a prenatal program such as the Nurse Family Partnership
- Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
- Inability to read English Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia...
See the full eligibility criteria
- Providing informed consent;
- Ability to read and speak English
- Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
- Self-identification as African American or Hispanics
- Age 18 to 45 years
- Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen.
- Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as...
- Willingness to adhere to the MLI regimen or usual care regimen
- After initial review of the electronic health record (EHR):
- Major systemic infections such as HIV, hepatitis
- \ 45 years of age
- Enrollment in a prenatal program such as the Nurse Family Partnership
- Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
- Inability to read English Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in...
- Only singleton pregnancies are included as the mechanisms of PTB are thought to differ with multiples.
- We do not exclude participants based on language (English or Spanish) spoken. We expect heterogeneity in language spoken and expect that there may be women who use both languages. Our prior study findings indicate that...
- Girls \<18 are excluded as the intervention is designed to improve emotional wellbeing and quality of life in mature adults; girls \<18 may not be cognitively ready for the adult intervention and may need an...
- We will control the use of progesterone treatment statistically.
- Women who develop gestational diabetes after enrolling in the study will remain in the study.
- At enrollment or during the study, anyone who is prescribed antidepressant or anti-anxiety medications will be eligible for the study. We will make note of it and control it in analysis. If a participant is referred for...
The study team makes the final eligibility decision.
Where it's taking place
- Webster, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Webster, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.