Mental Health Wellness 1MLINCT05012072
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
A study testing The Mastery Lifestyle Intervention in people with Mental Health Wellness 1 and Preterm Birth, run by Microgen LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Mental Health Wellness 1, Preterm Birth
- What is being tested?
- The Mastery Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 13 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathryn Tart, EdD, MSN, RN contact
United States1 site, 1 recruiting
- Recruiting
Women's Specialist of PLLC
Webster, Texas, 77598
Roberta J Ruiz, PhD, 281-300-5265, jruiz@microgenlabs.com
Roberta J Ruiz, PhD, 2813005265, raruiz20@central.uh.edu
About this study
Official title: Reductions in Biopsychosocial Risks for Pregnant Latina Women and Their Infants: The Mastery Lifestyle Intervention (MLI)
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.
Read the detailed description
To address the gaps related to interventions for Hispanic Mexican American and African American pregnant women, the investigators have developed and successfully pilot tested the Mastery Lifestyle Intervention (MLI): a culturally-relevant, manualized psychosocial group intervention that integrates two evidence-based behavioral therapies - Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). The MLI is a 6-week program designed to be integrated into regular prenatal care to facilitate more comprehensive care delivered by a nurse practitioner (NP) or certified nurse midwife (CNM). We propose the following hypotheses for a randomized controlled trial: Hypothesis 1a: Participants in the 6-week MLI will have decreased depressive symptoms, anxiety, stress, disengaged coping, and increased active coping compared to UC at end-of-treatment and after 6 weeks. Hypothesis 1b: The effects of MLI versus UC on depression, anxiety, stress, acculturative stress, and coping will be mediated via psychological flexibility and moderated by acculturation. Hypothesis 2a: Compared to UC, MLI participants will have significantly lower mean levels of CRH over time from baseline to end-of-treatment. Hypothesis 2b: Compared to UC, MLI participants will have significantly higher progesterone levels and lower estriol levels (higher progesterone/estriol ratios) over time from baseline to end-of-treatment. Hypothesis 3: As compared to UC, infants from mothers in the MLI group will have longer gestational age, greater birth weight, and fewer NICU admissions.
- Conditions
- Mental Health Wellness 1, Preterm Birth
- Being tested
- The Mastery Lifestyle Intervention
- Keywords
- Latina, Pregnancy, Mental Health, Corticotropin Releasing Hormone, Progesterone, Estriol, Gestational age, African American women
- Medical subject headings
- Premature Birth, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mastery Lifestyle InterventionBehavioural
Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
| Study group | Role | What they receive |
|---|---|---|
| MLI Experimental group | Experimental | 6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 21-27 weeks in their prenatal care setting. Receives: Behavioral: The Mastery Lifestyle Intervention |
| Control usual prenatal care | No intervention | Only data collection but no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Self Report questionnaire GAD-7
Measured: Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Depression
Self Report questionnaire CES-D
Measured: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Stress
Self Report questionnaire-PSS
Measured: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Coping levels
Self Report questionnaire The Brief Cope
Measured: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Secondary outcomes (3)
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.
Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Measured: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.
Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Measured: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.
Measured: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Aug 2021
- Primary completion9 Mar 2026 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microgen LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Houston
- Responsible party
- Principal investigator, Roberta Jeanne Ruiz, University of Houston
- Investigators
- Roberta J Ruiz, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012072
- Sponsor's protocol ID
- 1
- Acronym
- MLI
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2021
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz RJ, Grimes K, Spurlock E, Stotts A, Northrup TF, Villarreal Y, Suchting R, Cernuch M, Rivera L, Stowe RP, Pickler RH. The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Dec 28;22(1):979. doi: 10.1186/s12884-022-05284-9.
PubMed 36577949Ruiz RJ, Newman M, Records K, Wommack JC, Stowe RP, Pasillas RM. Pilot Study of the Mastery Lifestyle Intervention. Nurs Res. 2019 Nov/Dec;68(6):494-500. doi: 10.1097/NNR.0000000000000384.
PubMed 31693556