Post Partum DepressionMMHNCT03777046
Maternal Mental Health in the Hospital Setting
A study testing SOC with Psychology Therapy (CBT) in people with Post Partum Depression, run by Michelle Lopez at 2 sites in United States.
Trial summary
Perinatal (around the time of birth) mental health disorders are common difficulties of pregnancy. Perinatal depression is made up of major and minor depressive events during pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers suffer from perinatal depression. 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
- Post Partum Depression
- What is being tested?
- SOC with Psychology Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2019to 22 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18 years old.
- Mothers of infants ≤365 days of age admitted to the acute care floors at Texas Children's Hospital Medical Center Campus and their infant based on date of birth in Epic.
- English or Spanish speaking mother.
- Willing and able to provide informed consent.
- Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to 10
- Ability to complete study protocol.
- NOTE: Inclusion item # 3 is as per their choice for bilingual mothers.
Who cannot join
- Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital Medical Center Campus based on address on demographic form.
- Mother is not the primary caregiver of infant(s) confirmed at time of informed consent.
- Enrollment in this study during previous hospitalization based on duplicate identified in database.
- Currently under care of psychiatrist or psychologist as reported in screening questionnaire.
- NOTE: Exclusion item #2 is self-reported by the mothers at the time of screening for eligibility for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital - Women's Pavilion
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations
Perinatal (around the time of birth) mental health disorders are common difficulties of pregnancy. Perinatal depression is made up of major and minor depressive events during pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers suffer from perinatal depression. However, rates may be significantly higher among some subpopulations.
Left untreated, post partum depression (PPD) is linked with several significant negative health impacts on the mother, her infant, and their families. PPD is linked with lower quality maternal-child relationship, and this change in emotional attachment can lead to physiologic changes and poorer cognitive outcomes in the infant.
The purpose of this study is to determine the maternal mental health effect of postpartum depression screening and intervention during infants' short term hospitalizations. The study is also aiming to define effects of PPD short term hospitalization interventions on maternal PPD follow up and child health based on well child care (WCC), emergency department (ED) visits, hospital readmissions, and parent's feelings on child's health.
Read the detailed description
Study participants will complete a survey about their general needs and access to resources and a survey to screen for postpartum depression to determine if the participant will be enrolled. Based on the answers provided, the study team may recommend that the participant seek additional medical care, and may notify the participant's doctor, the child's doctor, and hospital officials if the study team believes that the participant needs further medical care for depression.
Half of the study participants will receive a social work consult and treatment with psychology therapy in the hospital. The psychology therapy will be 2-3 fifty-minute therapy sessions while the child is in the hospital. An outpatient psychiatry/psychology follow up appointment will be offered if needed as per routine care.
Discharge Follow Up:
A discharge follow up questionnaire and survey will be completed on an electronic tablet around the time of the baby's discharge home from the hospital or within 1 week of being at home. The survey can be completed over the phone or it can be sent via email or text to complete the survey online.
One Month Follow Up:
A one-time follow up questionnaire and survey will be completed 1 month after discharge from the hospital. The survey can be completed in approximately 5 - 10 minutes over the phone or it can be sent via email or text to complete the survey online.
The other half of the study participants will receive social work consult with information about follow up options for PPD per current standard of care for mothers identified as having postpartum depression in the hospital setting.
As part of this study a review of the child's medical record, including data collection, will be performed.
- Conditions
- Post Partum Depression
- Being tested
- Standard of Care (SOC), SOC with Psychology Therapy (CBT)
- Keywords
- PPD, Post Partum, Post Partum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Behavioural
Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.
SOC with Psychology Therapy (CBT)Behavioural
Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Screen fail subjects | No intervention | Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS) |
| PPD Control subjects | Active comparator | Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD. Receives: Behavioral: Standard of Care (SOC) |
| PPD Intervention subjects | Experimental | Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital. Receives: Behavioral: SOC with Psychology Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in PPD score
PPD score will be measured using the Edinburgh Postnatal Depression Scale (EPDS). A score less than 8 suggests depression is not likely. A score of 9-11 suggests depression is possible. A score of 12-13 indicates fairly high possibility of depression. A score of 14 and higher suggest probable depression. Positive score of 1, 2 or 3 on question 10 suggests there is a suicidality risk.
Measured: at Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start24 Jan 2019
- Primary completion13 Mar 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Lopez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle Lopez, Baylor College of Medicine
- Investigators
- Michelle Lopez, MD, Principal investigator, Texas Children's Hospital/Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777046
- Sponsor's protocol ID
- H44040
- Acronym
- MMH
- Status last verified
- Feb 2023
- First submitted
- 13 Dec 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations
- ClinicalTrials.gov ID
- NCT03777046
- Acronym / sponsor ID
- MMH / H44040
- Conditions
- Post Partum Depression
- Keywords
- PPD, Post Partum, Post Partum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Michelle LopezUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 17 Dec 2018 (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.
Perinatal (around the time of birth) mental health disorders are common difficulties of pregnancy. Perinatal depression is made up of major and minor depressive events during pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers suffer from perinatal depression. However, rates may be significantly higher among some subpopulations.
Left untreated, post partum depression (PPD) is linked with several significant negative health impacts on the mother, her infant, and their families. PPD is linked with lower quality maternal-child relationship, and this change in emotional attachment can lead to physiologic changes and poorer cognitive outcomes in the infant.
The purpose of this study is to determine the maternal mental health effect of postpartum depression screening and intervention during infants' short term hospitalizations. The study is also aiming to define effects of PPD short term hospitalization interventions on maternal PPD follow up and child health based on well child care (WCC), emergency department (ED) visits, hospital readmissions, and parent's feelings on child's health.
Detailed description
Study participants will complete a survey about their general needs and access to resources and a survey to screen for postpartum depression to determine if the participant will be enrolled. Based on the answers provided, the study team may recommend that the participant seek additional medical care, and may notify the participant's doctor, the child's doctor, and hospital officials if the study team believes that the participant needs further medical care for depression.
Half of the study participants will receive a social work consult and treatment with psychology therapy in the hospital. The psychology therapy will be 2-3 fifty-minute therapy sessions while the child is in the hospital. An outpatient psychiatry/psychology follow up appointment will be offered if needed as per routine care.
Discharge Follow Up:
A discharge follow up questionnaire and survey will be completed on an electronic tablet around the time of the baby's discharge home from the hospital or within 1 week of being at home. The survey can be completed over the phone or it can be sent via email or text to complete the survey online.
One Month Follow Up:
A one-time follow up questionnaire and survey will be completed 1 month after discharge from the hospital. The survey can be completed in approximately 5 - 10 minutes over the phone or it can be sent via email or text to complete the survey online.
The other half of the study participants will receive social work consult with information about follow up options for PPD per current standard of care for mothers identified as having postpartum depression in the hospital setting.
As part of this study a review of the child's medical record, including data collection, will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screen fail subjects | No intervention | –Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS) |
| PPD Control subjects | Active comparator | Behavioral: Standard of Care (SOC)Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD. |
| PPD Intervention subjects | Experimental | Behavioral: SOC with Psychology Therapy (CBT)Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years old.
- Mothers of infants ≤365 days of age admitted to the acute care floors at Texas Children's Hospital Medical Center Campus and their infant based on date of birth in Epic.
- English or Spanish speaking mother.
- Willing and able to provide informed consent.
- Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to 10
Key exclusion criteria (5 listed)
- Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital Medical Center Campus based on address on demographic form.
- Mother is not the primary caregiver of infant(s) confirmed at time of informed consent.
- Enrollment in this study during previous hospitalization based on duplicate identified in database.
- Currently under care of psychiatrist or psychologist as reported in screening questionnaire.
- NOTE: Exclusion item #2 is self-reported by the mothers at the time of screening for eligibility for the study.
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 |
|---|---|---|
| Standard of Care (SOC)Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD. | Behavioural | PPD Control subjects |
| SOC with Psychology Therapy (CBT)Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital. | Behavioural | PPD Intervention subjects |
Primary outcome
Difference in PPD score
Time frame: at Month 1
PPD score will be measured using the Edinburgh Postnatal Depression Scale (EPDS). A score less than 8 suggests depression is not likely. A score of 9-11 suggests depression is possible. A score of 12-13 indicates fairly high possibility of depression. A score of 14 and higher suggest probable depression. Positive score of 1, 2 or 3 on question 10 suggests there is a suicidality risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michelle Lopez, MD principal investigator
Texas Children's Hospital/Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC with Psychology Therapy (CBT) in people with Post Partum Depression, run by Michelle Lopez at 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in PPD score (time frame: at Month 1). 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 14 Feb 2023.