Roo Study on Mom and Baby Well-Being

NCT03809598 | Completed

• 1 other identifier: R00MH111805
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Maternal Psychological Distress; Prenatal Stress; Infant Development; Functional Neuroimaging; Pregnancy Related

Keywords

Infant MRI; Brain Development; MBCT; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intake - 34 Weeks GA (T5)

Secondary Outcomes (5)

• Blood assay for inflammatory marker IL6

  34 Weeks GA (T5)

• Maternal Cortisol

  34 Weeks GA (T5)

• Neonatal Resting State fMRI scan

  Infant Scan (T6)

• Neonatal Structural MRI scan

  Infant Scan (T6)

• Maternal Pregnancy Specific Psychological Stress

  Intake - 34 weeks (T5)

Study Arms (2)

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.

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.

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description

Also known as: Mindfulness Based Cognitive Therapy for Perinatal Depression

Mindfulness Based Cognitive Therapy

Eligibility Criteria

• Age: 3 Days - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 26654212 BACKGROUND

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alice Graham, PHD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Alice Graham

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 18, 2019
• Study Start: March 1, 2019
• Primary Completion: May 24, 2022
• Study Completion: September 1, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: In accord with the NIMH Data Archive Data Submission Agreement policies we will share data on a semi-annual basis beginning 6-months after initiating data collection and through the end of the study.
• Access Criteria: Data will be available through the NIMH Data Archive by following the procedures for Data Use Certification.

Locations

US (1)