Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Prenatal Stress; Postpartum Depression; Maternal Psychological Distress

Treatments: Behavioral: Mindfulness Based Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03809572

1R21AT010292-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Mindfulness Based Cognitive Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

Treatment as usual (TAU)

No Intervention group

Description:

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.