Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
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. |
Primary Purpose: | Prevention |
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 2022 |
Estimated Study Completion Date : | November 2022 |
Arm | Intervention/treatment |
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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.
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Behavioral: Mindfulness Based Cognitive Therapy
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
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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.
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Ages Eligible for Study: | up to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Pregnant Women/ Mothers:
Inclusion and exclusion criteria for pregnant women/ mothers will be determined by a combination of the initial screen and intake assessment.
Inclusion criteria include:
Exclusion criteria include:
Infants:
Inclusion for infants to participate in MRI scan include:
not meeting any of the exclusion criteria below.
Exclusion criteria for infants (specifically exclusionary for MRI scan) include:
Contact: Julia S Grieser Painter, PhD | 5034181898 | grieserp@ohsu.edu | |
Contact: Gracie Arnone, BS | arnone@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Julia Grieser Painter, PhD 503-418-1898 grieserp@ohsu.edu | |
Contact: Gracie Arnone, BS 5034944476 arnone@ohsu.edu | |
Principal Investigator: Alice Graham, PHD | |
Sub-Investigator: Kristen Mackiewicz Seghete, PHD |
Principal Investigator: | Alice Graham, PHD | Oregon Health and Science University |
Tracking Information | |||||||||||
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First Submitted Date ICMJE | January 9, 2019 | ||||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||||
Last Update Posted Date | April 1, 2021 | ||||||||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Roo Study on Mom and Baby Well-Being | ||||||||||
Official Title ICMJE | A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes | ||||||||||
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. | ||||||||||
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 Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||
Study Design ICMJE | Allocation: Randomized 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. Primary Purpose: Prevention
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Mindfulness Based Cognitive Therapy
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
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Study Arms ICMJE |
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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. | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||
Estimated Enrollment ICMJE |
172 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | November 2022 | ||||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE |
Pregnant Women/ Mothers: Inclusion and exclusion criteria for pregnant women/ mothers will be determined by a combination of the initial screen and intake assessment. Inclusion criteria include:
Exclusion criteria include:
Infants: Inclusion for infants to participate in MRI scan include:
Exclusion criteria for infants (specifically exclusionary for MRI scan) include:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 45 Years (Child, Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT03809598 | ||||||||||
Other Study ID Numbers ICMJE | R00MH111805( U.S. NIH Grant/Contract ) | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Alice Graham, Oregon Health and Science University | ||||||||||
Study Sponsor ICMJE | Oregon Health and Science University | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | ||||||||||
Verification Date | March 2021 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |