Maternal Psychological DistressNCT03809598
Roo Study on Mom and Baby Well-Being
A study testing Mindfulness Based Cognitive Therapy in people with Maternal Psychological Distress and Prenatal Stress, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain systems integral to… Read more about this study
- Who is it for?
- Ages 3 days to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Psychological Distress, Prenatal Stress, Infant Development
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Sep 2022
- 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 3 days to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- be 21-45 years old
- be a female who is currently pregnant (8-22 weeks GA at screening)
- fluently speak English
- be available and physically able to attend group scheduled meetings
- have a single gestation, and
- have a history of an internalizing psychiatric disorder.
Show all 15Show fewer
- being between 37 and 50 weeks gestational age (GA) equivalent at time of 1st scan*
- not meeting any of the exclusion criteria below.
- We are using GA equivalent rather than postnatal age because infants born pre-term will not be scanned prior to term equivalent (37 weeks GA). Therefore, infants who are born preterm may be older in terms of postnatal age, but will be similar to infants born at term with regard to time since conception. The time since conception is more pertinent to our measures of brain development versus postnatal age.
- Exclusion criteria for infants (specifically exclusionary for MRI scan) include:
- congenital, genetic, or neurologic disorder (e.g., Down syndrome, fragile X)
- major neurologic disorder at birth (e.g., bacterial meningitis, epilepsy)
- birth < 30 weeks GA
- medical complications following birth requiring ongoing hospitalization.
- medical complications or health problems at or following birth, which could make an MRI scan unsafe or uncomfortable
Who cannot join
- Major neurological or medical condition (e.g., diabetes, MS),
- IQ <80
- maternal use of psychotropic medications, insulin, or any other medications that might impact the central nervous system (at the time of enrollment)
- current diagnosis of substance use disorder, illicit drug use or nicotine use
- diagnosis of autism, developmental disorder involving intellectual disability or a psychotic disorder
- current major depressive episode, eating disorder or manic episode
Show all 12Show fewer
- current active suicidality and/or homicidally, or interpersonal violence
- prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., MBCT, MBSR, DBT (mindfulness module))
- pregnancy-specific medical conditions or complications including placental abnormality or other conditions requiring bed rest
- known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
- uncorrectable vision or hearing impairments (including color blindness)
- Infants:
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes
This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain systems integral to healthy and maladaptive emotion regulation. This study considers other potential influences on maternal stress and psychiatric symptomatology, and infant behavior and brain development. The study population is pregnant women aged 21-45, and their infants.
Read the detailed description
The study will involve an online screen of potentially eligible pregnant women. If women are eligible after the online screen, they will be invited in for an in-person assessment, including cognitive testing and a diagnostic interview, to further determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to a Mindfulness Based Cognitive Therapy (MBCT) group involving an 8-session group-based intervention or to treatment as usual (TAU) during pregnancy followed by one mindfulness psychoeducation session postpartum. Eligible participants will then be invited in for a study visit during which they will give blood, urine, and saliva samples. Participants in the MBCT group will complete questionnaires prior to the 1st group session, after the 4th session, and after the 8th/final session. Participants in the TAU group will complete the same questionnaires at equivalent time points. All participants will come in for an in-person session at 34 weeks GA, during which they will complete questionnaires, a brief clinical interview and provide blood, urine, and saliva samples again. Participants will then come in with their infant for the infant MRI scan within one month of giving birth. Study staff will collect a hair and saliva sample from the infant at this time. Participants will have a remote visit at 6 weeks postpartum, during which time they will complete questionnaires and a clinical interview. At 6 months postpartum, participants will return for their final visit, during which they will complete questionnaires and a clinical interview. Mothers and infants will also provide a hair sample at this time. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.
- Conditions
- Maternal Psychological Distress, Prenatal Stress, Infant Development, Functional Neuroimaging, Pregnancy Related
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Infant MRI, Brain Development, MBCT, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called Mindfulness Based Cognitive Therapy for Perinatal Depression
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | MBCT adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. The intervention is focused on skill development through active engagement in mindfulness practices and exercises to increase awareness of thoughts, feelings and behavior in session, and assignment and review of daily home practices. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as Usual | No intervention | All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own. They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate. For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment). The TAU group will be offered a delayed treatment option, after the 6 month follow-up. This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum. Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Psychological Stress
Maternal psychological stress will be a composite of the Perceived Stress Scale (PSS), Beck Anxiety Inventory (BAI), and Pregnancy Distress Questionnaire (PDQ) The magnitude and trajectory of maternal psychological stress will be examined.
Measured: Intake - 34 Weeks GA (T5)
Maternal Depression
Maternal depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). The magnitude and trajectory of maternal psychological stress will be examined.
Measured: Intake - 34 Weeks GA (T5)
Secondary outcomes (5)
Blood assay for inflammatory marker IL6
Levels of IL6 assayed from maternal blood samples. Difference in magnitude of inflammation between groups at T5 after adjusting for inflammation prior to the intervention.
Measured: 34 Weeks GA (T5)
Maternal Cortisol
The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention.
Measured: 34 Weeks GA (T5)
Neonatal Resting State fMRI scan
MRI scans with neonates will occur during natural sleep. Resting state functional connectivity will be the outcome of interest.
Measured: Infant Scan (T6)
Neonatal Structural MRI scan
MRI scans with neonates will occur during natural sleep. Neonatal subcortical brain structure volume will be the outcome of interest.
Measured: Infant Scan (T6)
Maternal Pregnancy Specific Psychological Stress
The Prenatal Distress Questionnaire (PDQ) is a short measure designed to assess specific worries and concerns related to pregnancy.
Measured: Intake - 34 weeks (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Mar 2019
- Primary completion24 May 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Psychological DistressStudies 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
- The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Graham, Oregon Health and Science University
- Investigators
- Alice Graham, PHD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809598
- Sponsor's protocol ID
- R00MH111805
- Status last verified
- Sep 2023
- First submitted
- 9 Jan 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We propose to share individual participant data in accord with the NIMH Data Archive Data Submission Agreement.
Publications
Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.
PubMed 26654212
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes
- ClinicalTrials.gov ID
- NCT03809598
- Acronym / sponsor ID
- R00MH111805
- Conditions
- Maternal Psychological Distress, Prenatal Stress, Infant Development, Functional Neuroimaging, Pregnancy Related
- Keywords
- Infant MRI, Brain Development, MBCT, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Jan 2019 (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.
This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain systems integral to healthy and maladaptive emotion regulation. This study considers other potential influences on maternal stress and psychiatric symptomatology, and infant behavior and brain development. The study population is pregnant women aged 21-45, and their infants.
Detailed description
The study will involve an online screen of potentially eligible pregnant women. If women are eligible after the online screen, they will be invited in for an in-person assessment, including cognitive testing and a diagnostic interview, to further determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to a Mindfulness Based Cognitive Therapy (MBCT) group involving an 8-session group-based intervention or to treatment as usual (TAU) during pregnancy followed by one mindfulness psychoeducation session postpartum. Eligible participants will then be invited in for a study visit during which they will give blood, urine, and saliva samples. Participants in the MBCT group will complete questionnaires prior to the 1st group session, after the 4th session, and after the 8th/final session. Participants in the TAU group will complete the same questionnaires at equivalent time points. All participants will come in for an in-person session at 34 weeks GA, during which they will complete questionnaires, a brief clinical interview and provide blood, urine, and saliva samples again. Participants will then come in with their infant for the infant MRI scan within one month of giving birth. Study staff will collect a hair and saliva sample from the infant at this time. Participants will have a remote visit at 6 weeks postpartum, during which time they will complete questionnaires and a clinical interview. At 6 months postpartum, participants will return for their final visit, during which they will complete questionnaires and a clinical interview. Mothers and infants will also provide a hair sample at this time. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyMBCT adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. The intervention is focused on skill development through active engagement in mindfulness practices and exercises to increase awareness of thoughts, feelings and behavior in session, and assignment and review of daily home practices. |
| Treatment as Usual | No intervention | –All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own. They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate. For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment). The TAU group will be offered a delayed treatment option, after the 6 month follow-up. This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum. Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities. |
Who may qualify
- Ages
- 3 days to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- be 21-45 years old
- be a female who is currently pregnant (8-22 weeks GA at screening)
- fluently speak English
- be available and physically able to attend group scheduled meetings
- have a single gestation, and
Key exclusion criteria (12 listed)
- Major neurological or medical condition (e.g., diabetes, MS),
- IQ <80
- maternal use of psychotropic medications, insulin, or any other medications that might impact the central nervous system (at the time of enrollment)
- current diagnosis of substance use disorder, illicit drug use or nicotine use
- diagnosis of autism, developmental disorder involving intellectual disability or a psychotic disorder
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 |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: Mindfulness Based Cognitive Therapy for Perinatal DepressionSee "Mindfulness Based Cognitive Therapy (MBCT) Arm" description | Behavioural | Mindfulness Based Cognitive Therapy |
Primary outcome
Maternal Psychological Stress
Time frame: Intake - 34 Weeks GA (T5)
Maternal psychological stress will be a composite of the Perceived Stress Scale (PSS), Beck Anxiety Inventory (BAI), and Pregnancy Distress Questionnaire (PDQ) The magnitude and trajectory of maternal psychological stress will be examined.
Maternal Depression
Time frame: Intake - 34 Weeks GA (T5)
Maternal depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). The magnitude and trajectory of maternal psychological stress will be examined.
5 secondary outcomes
Blood assay for inflammatory marker IL6
Time frame: 34 Weeks GA (T5)
Maternal Cortisol
Time frame: 34 Weeks GA (T5)
Neonatal Resting State fMRI scan
Time frame: Infant Scan (T6)
Neonatal Structural MRI scan
Time frame: Infant Scan (T6)
Maternal Pregnancy Specific Psychological Stress
Time frame: Intake - 34 weeks (T5)
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 29 Sep 2023.
- Background: PubMed 26654212Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.
- Individual participant dataSharing planned: Yes. We propose to share individual participant data in accord with the NIMH Data Archive Data Submission Agreement.
Related trials for Maternal Psychological Distress
Recruiting
Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
Mental Health, Parenting / Maternal Behavior
Active, not recruiting
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
Well-Being, Psychological, Dissociation
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.
Alice Graham, PHD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Maternal Psychological Distress and Prenatal Stress, run by Oregon Health and Science 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 15 inclusion and 12 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 29 Sep 2023. 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?
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?
Maternal Psychological Stress (time frame: Intake - 34 Weeks GA (T5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809598, which also lists 1 linked publication.
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 29 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.