Roo Study on Mom and Baby Well-Being
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|ClinicalTrials.gov Identifier: NCT03809598|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Maternal Psychological Distress Prenatal Stress Infant Development Functional Neuroimaging Pregnancy Related||Behavioral: Mindfulness Based Cognitive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Investigator, Outcomes Assessor)|
|Masking Description:||Given the use of a psychotherapeutic intervention involving participation in group sessions, participants and interventionists cannot be blinded to group assignment. The study is designed to minimize the extent to which study staff, aside from interventionists and the primary Study Coordinator(s), are aware of group assignment. The Study Coordinator(s) needs to know group assignment because they will inform participants of their group assignment and will communicate with participants regarding group attendance. The Study Coordinator(s) will be the main point of contact for participants throughout the study to reduce risk of participants revealing their group assignment to other study staff. Participants will be informed that only the Study Coordinator(s) and interventionists, if applicable, are aware of their group assignment. Therefore, in order to ensure the integrity of the research study, they should refrain from discussing their group assignment with other staff members.|
|Official Title:||A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Mindfulness Based Cognitive Therapy
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.
Behavioral: Mindfulness Based Cognitive Therapy
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
No Intervention: Treatment as Usual
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.
- 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 Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). This composite measure includes the degree to which situation's in one's life are appraised as stressful, perception of one's capacity to manage potentially stressful situations, as well as anxiety and depressive symptomatology. The magnitude and trajectory of maternal psychological stress will be examined.
- Blood assay for inflammatory marker IL6 [ Time Frame: 34 Weeks GA (T5) ]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.
- Maternal Cortisol [ Time Frame: 34 Weeks GA (T5) ]The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention.
- Neonatal Resting State fMRI scan [ Time Frame: Infant Scan (T6) ]MRI scans with neonates will occur during natural sleep. Resting state functional connectivity will be the outcome of interest.
- Neonatal Structural MRI scan [ Time Frame: Infant Scan (T6) ]MRI scans with neonates will occur during natural sleep. Neonatal subcortical brain structure volume will be the outcome of interest.
- Maternal Pregnancy Specific Psychological Stress [ Time Frame: Intake - 34 weeks (T5) ]The Prenatal Distress Questionnaire (PDQ) is a short measure designed to assess specific worries and concerns related to pregnancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809598
|Contact: Evelyn Jackson, BAemail@example.com|
|Contact: Olivia Doyle, BAfirstname.lastname@example.org|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Evelyn Jackson, BA 503-494-4476 email@example.com|
|Contact: Olivia Doyle, BA 5034181898 firstname.lastname@example.org|
|Principal Investigator: Alice Graham, PHD|
|Sub-Investigator: Kristen Mackiewicz Seghete, PHD|
|Principal Investigator:||Alice Graham, PHD||Oregon Health and Science University|