AnxietyNCT05838404
M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
A study testing M-O-M-S on the Bayou in people with Anxiety and Depression, run by Tulane University at 1 site in United States.
Trial summary
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- M-O-M-S on the Bayou
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant
- Below 20 weeks' gestation
- Enrolled in prenatal care
Who cannot join
- Not pregnant
- Under age 18
- Does not speak English or Spanish
- Does not plan to carry to term
- Does not plan to remain in the study area through pregnancy
- Fetal defects likely to lead to death or extensive hospitalization postpartum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tulane University
New Orleans, Louisiana, 70112
Emily Harville, 504-988-7327
Andrea Meyer, 504-988-8803
About this study
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region.
The main questions this intervention aims to answer are:
Read more
- Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment.
- Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment.
The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.
Read the detailed description
The M-O-M-S™ (Mentors Offering Maternal Support) intervention is based in a theoretical framework addressing the major transitions that occur with pregnancy and close relationship processes. Weis et al. found that community esteem-building support, focused in first and second trimester, decreased anxiety associated with pregnancy and maternal adaptation. The M-O-M-S™ intervention was specifically designed to address pregnancy-specific anxiety (inclusive of depressive symptoms), concerns related to family/partner relationships, and provide esteem-building peer support, with each session directly aligned to specific aspects of anxiety and depression pertinent to the point in pregnancy for the women. Women are recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor", a mother who has experienced pregnancy, labor, and motherhood.
Up to 400 subjects will be recruited, with a goal of 240 completing the study. Each group will consist of 15-20 recruits, assuming a degree of attrition that will lead to group sizes of 10-12. The outcome measures will be compared between the intervention and control data and linear regression (with adjustment for partial clustering) used to adjust for differences in participant characteristics. Given an estimated effect size and variance (both pre-post and intervention-control) from previous trials, 240 participants gives good power for reasonable effect sizes for both the pre-post analysis and intervention-control analyses incorporating a design (cluster) effect.
Recruitment will take place at ob/gyn practices, WIC clinics, health units, and at community sites. Clinicians will be informed of the intervention and asked to encourage their patients to participate. They will also refer potential participants and provide flyers to interested women. Study staff will also attend the clinics on days when a large number of prenatal visits are scheduled, and clinic staff will inform them who can be approached as a potential participant. Flyers and posters will also be provided to participating clinics, and participants can self-refer. Participants will be contacted via the method they indicate they prefer.
Participants will attend 6 group meetings lasting 1 hr. every other week. These sessions are aimed at decreasing pregnancy concerns and building coping skills through supportive relationships with experienced local mothers and the other participants in the group. The meetings are closed group sessions.
Participants also receive a "Birth of a Mother" manual designed to guide open discussion during the course of the sessions.
In addition, participants will complete questionnaires at baseline and at the end of the intervention about their mental health, experience of the intervention, and disaster experience.
- Conditions
- Anxiety, Depression
- Being tested
- M-O-M-S on the Bayou
- Keywords
- Pregnancy, Pregnancy-related anxiety
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-O-M-S on the BayouBehavioural
Peer and mentor support and meetings across pregnancy
| Study group | Role | What they receive |
|---|---|---|
| MOMS on the Bayou Intervention Group | Experimental | Participants complete intervention protocol. Receives: Behavioral: M-O-M-S on the Bayou |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-specific anxiety
Score on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ), Scale of 1-4; 1 = worse outcome; 4 = better outcome.
Measured: 12 weeks
Secondary outcomes (1)
Depressive symptoms
Score on Edinburgh Postnatal Depression Scale (EPDS), Scale of 1-4; 1 = better outcome; 4 = worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Nov 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838404
- Sponsor's protocol ID
- 2022-1533
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from the intervention will be provided to the Gulf Research Program.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
- ClinicalTrials.gov ID
- NCT05838404
- Acronym / sponsor ID
- 2022-1533
- Conditions
- Anxiety, Depression
- Keywords
- Pregnancy, Pregnancy-related anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region.
The main questions this intervention aims to answer are:
- Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment.
- Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment.
The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.
Detailed description
The M-O-M-S™ (Mentors Offering Maternal Support) intervention is based in a theoretical framework addressing the major transitions that occur with pregnancy and close relationship processes. Weis et al. found that community esteem-building support, focused in first and second trimester, decreased anxiety associated with pregnancy and maternal adaptation. The M-O-M-S™ intervention was specifically designed to address pregnancy-specific anxiety (inclusive of depressive symptoms), concerns related to family/partner relationships, and provide esteem-building peer support, with each session directly aligned to specific aspects of anxiety and depression pertinent to the point in pregnancy for the women. Women are recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor", a mother who has experienced pregnancy, labor, and motherhood.
Up to 400 subjects will be recruited, with a goal of 240 completing the study. Each group will consist of 15-20 recruits, assuming a degree of attrition that will lead to group sizes of 10-12. The outcome measures will be compared between the intervention and control data and linear regression (with adjustment for partial clustering) used to adjust for differences in participant characteristics. Given an estimated effect size and variance (both pre-post and intervention-control) from previous trials, 240 participants gives good power for reasonable effect sizes for both the pre-post analysis and intervention-control analyses incorporating a design (cluster) effect.
Recruitment will take place at ob/gyn practices, WIC clinics, health units, and at community sites. Clinicians will be informed of the intervention and asked to encourage their patients to participate. They will also refer potential participants and provide flyers to interested women. Study staff will also attend the clinics on days when a large number of prenatal visits are scheduled, and clinic staff will inform them who can be approached as a potential participant. Flyers and posters will also be provided to participating clinics, and participants can self-refer. Participants will be contacted via the method they indicate they prefer.
Participants will attend 6 group meetings lasting 1 hr. every other week. These sessions are aimed at decreasing pregnancy concerns and building coping skills through supportive relationships with experienced local mothers and the other participants in the group. The meetings are closed group sessions.
Participants also receive a "Birth of a Mother" manual designed to guide open discussion during the course of the sessions.
In addition, participants will complete questionnaires at baseline and at the end of the intervention about their mental health, experience of the intervention, and disaster experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOMS on the Bayou Intervention Group | Experimental | Behavioral: M-O-M-S on the BayouParticipants complete intervention protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- Below 20 weeks' gestation
- Enrolled in prenatal care
Key exclusion criteria (6 listed)
- Not pregnant
- Under age 18
- Does not speak English or Spanish
- Does not plan to carry to term
- Does not plan to remain in the study area through pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-O-M-S on the BayouPeer and mentor support and meetings across pregnancy | Behavioural | MOMS on the Bayou Intervention Group |
Primary outcome
Pregnancy-specific anxiety
Time frame: 12 weeks
Score on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ), Scale of 1-4; 1 = worse outcome; 4 = better outcome.
1 secondary outcome
Depressive symptoms
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified data from the intervention will be provided to the Gulf Research Program.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-O-M-S on the Bayou in people with Anxiety and Depression, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Harville, PhD (504-988-7327, eharvill@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-specific anxiety (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.