Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy

NCT03809572 | Terminated DMC

• 1 other identifier: 1R21AT010292-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. This study examines emotion regulation as a potential mechanism of action, at both the behavioral and neurobiological level, that carries forward to the postpartum period. A secondary mechanism of action to be explored is cognitive control. This study will also consider other potential influences on treatment response and psychiatric outcomes, including perinatal stress and depressive symptoms. The study population is pregnant women age 21-45.

Conditions

Maternal Psychological Distress; Postpartum Depression; Prenatal Stress

Keywords

fMRI; pregnancy; postpartum; MBCT; Mindfulness Based Cognitive Therapy; emotion regulation

Outcome Measures

Primary Outcomes (5)

• Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)

  Self-reported depressive symptoms over the past two weeks. There are 20 items, each scored from 0-4. The total score range is from 0-80. Total score will be used, with higher scores indicate more depressive symptoms.

  6 Weeks Postpartum

• Emotion Regulation Questionnaire (ERQ)

  Self-report of emotion regulation skills. There are two primary subscales, cognitive reappraisal (range: 6-42) and expressive suppression (range: 4-28). Outcome will be total score on the cognitive reappraisal scale. Higher scores for reappraisal indicate better emotion regulation.

  6 Weeks Postpartum

• Stroop Task

  The classic Stroop task is a robust measure of cognitive control. Participants will view a color word in a different color ink, naming the ink color. A control condition is included with neutral words. Interference score will be calculated using reaction times.

  6 Weeks Postpartum

• Brain activation during an emotion regulation task

  An emotion regulation task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation. Individuals will view negative and neutral pictures from the International Affective Picture System. For some pictures, they will just view the images. For some negative pictures, they will be asked to regulate their responding using a distancing technique that has been introduced to them.

  6 Weeks Postpartum

• Brain activation during the Stroop task

  The Stroop task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation when cognitive control must be exerted.

  6 Weeks Postpartum

Secondary Outcomes (4)

• Rate of Postpartum Depression

  6 Weeks Postpartum, 6 Months Postpartum

• Emotion Regulation Questionnaire (ERQ)

  6 Months Postpartum

• Stroop Task

  6 Months Postpartum

• Infant Behavior Questionnaire - Revised (IBQ-R)

  6 Months Postpartum

Study Arms (2)

Mindfulness Based Cognitive Therapy

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.

Behavioral: Mindfulness Based Cognitive Therapy

Treatment as usual (TAU)

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 Arm description

Also known as: Mindfulness Based Cognitive Therapy for Perinatal Depression

Mindfulness Based Cognitive Therapy

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
• years old
• single gestation
• fluently speak English
• be available and physically able to attend scheduled group meetings
• have a prior history of at least 1 major depressive episode (as determined through psychiatric interviewing).
• Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
• major neurological or medical illness (e.g., diabetes, multiple sclerosis)
• history of head trauma (loss of conscious \> 2 minutes)
• Intelligence Quotient (IQ) \< 80
• uncorrectable vision or hearing impairments (including color blindness)
• use of psychotropic medications, corticosteroids, insulin, or any other medications that might impact the central nervous system
• current illicit drug use or diagnosis of a current substance use disorder
• current diagnosis of an eating disorder
• current depressive or manic episode

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

Conditions

Depression, Postpartum; Emotional Regulation

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristen Mackiewicz Seghete, 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 group therapy, 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 be the main point of contact for participants throughout the study, as 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: Assistant Professor

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. Randomization will be stratified based on current depressive symptoms and current stress levels.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 18, 2019
• Study Start: March 22, 2019
• Primary Completion: October 1, 2020
• Study Completion: March 8, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after final data collection is concluded through 5 years after publication
• Access Criteria: The Principal Investigator (PI) will review requests for individual participant data (IPD). IPD will be provided with appropriate Institutional Review Board (IRB) approval or determination of IRB exemption and approval by the National Center for Complementary and Integrative Health (NCCIH) program officer. IPD may be provided to investigators associated with a university or reputable research institution with an associated IRB. De-identified IPD will be provided through a secure sharing mechanism.

Locations

US (1)