Back to search results

The Mastery Lifestyle Intervention for Reducing Pregnancy Risks

This study is testing a program called The Mastery Lifestyle Intervention (MLI) to help reduce pregnancy risks like preterm birth and improve mental well-being. The MLI is a behavioral intervention that combines two types of therapy: Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). Researchers want to see if MLI can lower anxiety, depression, and stress in pregnant women. You might be able to join if you are a woman between 18 and 45 years old, 14-20 weeks pregnant with one baby, identify as African American or Hispanic, and live in the U.S. The study aims to enroll 238 participants. Success would mean participants in the MLI group show reduced anxiety, depression, and stress compared to those receiving standard prenatal care. The current status of this study is unclear.

Study design
This is a randomized controlled trial planning to enroll 238 pregnant women. Participants will either receive the Mastery Lifestyle Intervention or standard prenatal care.
What's involved
Participants will attend 6 group sessions as part of the Mastery Lifestyle Intervention. Your anxiety, depression, and stress will be measured at 14-20 weeks, 21-27 weeks, and 32-36 weeks pregnant.
Compensation
Not stated in the trial record.
Follow-up
The study will assess changes in anxiety, depression, and stress up to 32-36 weeks pregnant. They will also determine any effect on infant outcomes at delivery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05012072

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Recruiting
NAAges 18–45InterventionalPrevention
Microgen LLC
~238 participants
Updated 2025-07-17 on ClinicalTrials.gov
What's tested:The Mastery Lifestyle Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anxiety
Measured over Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
+3 more outcomes measured

Conditions

Mental Health Wellness 1
Preterm Birth

Explore related trials

Pregnancy

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Roberta J Ruiz, PhD · PRINCIPAL_INVESTIGATOR · University of Houston

Who to contact

Roberta J. Ruiz, PhD
[email protected]
2813005265
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • AnxietyAssessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

    Self Report questionnaire GAD-7

  • DepressionAssessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

    Self Report questionnaire CES-D

  • StressAssessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

    Self Report questionnaire-PSS

  • Coping levelsAssessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

    Self Report questionnaire The Brief Cope