Clinical trial NCT03809572: Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
Official title: Mechanisms of Action of MBCT-PD: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Maternal Psychological Distress
Postpartum Depression
Prenatal Stress
Keywords: fMRI
pregnancy
postpartum
MBCT
Mindfulness Based Cognitive Therapy
emotion regulation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 56
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. Randomization will be stratified based on current depressive symptoms and current stress levels.
Primary purpose: PREVENTION

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.

Detailed description: The study will involve an online screen of potentially eligible pregnant women. If participants are eligible after the online screen, they will be invited in for an in person assessment, including cognitive testing and a diagnostic interview, to determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to Mindfulness Based Cognitive Therapy (MBCT) or treatment as usual (TAU). Participants in the MBCT group will complete 8 weekly, 2 hr group therapy sessions during pregnancy, as well as receive TAU. The TAU group will engage in regular care during pregnancy and be offered the option to attend one mindfulness psychoeducation session postpartum. 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 and a brief clinical interview. Participants will come in for an MRI scan session at 6 weeks postpartum. In addition to structural and functional MRI scanning, they will also complete questionnaires, a cognitive task, and brief psychiatric interview. At 6 months postpartum, participants will return for a visit, during which they will complete questionnaires, cognitive measures, and a clinical interview. This will be the final visit for women in the MBCT group. Women in the TAU group will complete a singe mindfulness psychoeducation session between 6 and 9 months postpartum; this must occur after their 6 month visit. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.

Eligibility criteria: Inclusion:

1. female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
2. 21-45 years old
3. single gestation
4. fluently speak English
5. be available and physically able to attend scheduled group meetings
6. have a prior history of at least 1 major depressive episode (as determined through psychiatric interviewing).

Exclusion (at enrollment):

1. Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
2. major neurological or medical illness (e.g., diabetes, multiple sclerosis)
3. history of head trauma (loss of conscious \> 2 minutes)
4. Intelligence Quotient (IQ) \< 80
5. uncorrectable vision or hearing impairments (including color blindness)
6. use of psychotropic medications, corticosteroids, insulin, or any other medications that might impact the central nervous system
7. current illicit drug use or diagnosis of a current substance use disorder
8. current diagnosis of an eating disorder
9. current depressive or manic episode
10. diagnosis of a neurodevelopmental disorder (Autism, Intellectual Disability)
11. any history of psychosis
12. current active suicidality and/or homicidality, or interpersonal violence
13. prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., Mindfulness Based Cognitive Therapy (MBCT), Mindfulness Based Stress Reduction (MBSR), Dialectical Behavior Therapy (DBT))
14. known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
15. pregnancy-specific medical conditions or complications that significantly increase risk (e.g., placental separation, placenta previa)
16. History of meningitis or seizures (except infantile or febrile)

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
timeFrame: 6 Weeks Postpartum
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 6 Weeks Postpartum
measure: Stroop Task
timeFrame: 6 Weeks Postpartum
measure: Brain activation during an emotion regulation task
timeFrame: 6 Weeks Postpartum
measure: Brain activation during the Stroop task
timeFrame: 6 Weeks Postpartum
Secondary outcomes:
measure: Rate of Postpartum Depression
timeFrame: 6 Weeks Postpartum, 6 Months Postpartum
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 6 Months Postpartum
measure: Stroop Task
timeFrame: 6 Months Postpartum
measure: Infant Behavior Questionnaire - Revised (IBQ-R)
timeFrame: 6 Months Postpartum
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kristen Mackiewicz Seghete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.