Is NCT05012072 recruiting in Webster, TX?

Yes, NCT05012072 is currently recruiting participants at its Webster, TX location. This mental health wellness 1 clinical trial is actively enrolling qualified participants.

How do I join the mental health wellness 1 clinical trial in Webster?

To join this clinical trial in Webster, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Webster clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mental Health Wellness 1 Clinical Trial in Webster, TX

About This Mental Health Wellness 1 Study in Webster

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. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

Sponsor: Microgen LLC

Who Can Participate

Inclusion 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 administered by clinical staff of the participating provider

Willingness to adhere to the MLI regimen or usual care regimen

Exclusion Criteria

After initial review of the electronic health record (EHR):

Major systemic infections such as HIV, hepatitis

\<18 years of age or \>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 analysis of infant outcomes. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the exclusion criteria is:

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 the risk of PTB is greatest among English-speaking and bilingual women, although we believe that all women will receive benefit from the MLI.

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 intervention tailored to their stage of development. Girls under 18 also have a different set of risks than women over 18 years of age.

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 individual therapy, we will obtain data from the prenatal record and control for that in the analysis

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Webster?

Yes, this clinical trial (NCT05012072) has an active research site in Webster, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mental Health Wellness 1 Treatment Options in Webster, TX

If you're searching for mental health wellness 1 treatment options in Webster, TX, this clinical trial (NCT05012072) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Webster research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mental health wellness 1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mental health wellness 1 clinical trials near you to find additional studies recruiting in your area.

Mental Health Wellness 1 Clinical Trial in Webster, TX

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