Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy

Postpartum Depression Clinical Trial

Official title:

Mechanisms of Action of MBCT-PD: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03809572
• Other study ID #: 1R21AT010292-01
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: March 8, 2021

Study information

• Verified date: December 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: March 8, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression, Postpartum
• Maternal Psychological Distress
• Postpartum Depression
• Prenatal Stress

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
See Arm description

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Rate of Postpartum Depression	Presence of a major depressive episode will be used to determine the presence of postpartum depression. Major depressive episodes will be assessed using the Mood Module of the Structured Clinical Interview for the Diagnostic and Statistical Manual, Fifth Edition (SCID-5).	6 Weeks Postpartum, 6 Months Postpartum
Secondary	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 Months Postpartum
Secondary	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 Months Postpartum
Secondary	Infant Behavior Questionnaire - Revised (IBQ-R)	A 193 item self-report measure completed by mothers about specific temperament-related behaviors displayed by their infant over the past two weeks. There are 14 sub-scales derived, each ranging from 0-7. A negative emotionality composite will be derived from the fear, sadness, and distress to limitations sub-scales.	6 Months Postpartum