Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
Status: | Not yet recruiting |
---|---|
Conditions: | Depression, Women's Studies |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 21 - 45 |
Updated: | 3/15/2019 |
Start Date: | March 21, 2019 |
End Date: | June 30, 2020 |
Contact: | Evelyn Jackson, BA |
Email: | jacksone@ohsu.edu |
Phone: | 5034944476 |
Mechanisms of Action of MBCT-PD: A Pilot Study
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.
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.
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.
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.
Inclusion:
1. female who is currently pregnant (8-18 weeks gestational age (GA) at time of screen)
2. 21-45 years old
3. primiparous
4. single gestation
5. fluently speak English
6. be available and physically able to attend scheduled group meetings
7. 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, pregnant
or suspect they could be pregnant on the day of the scan)
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 substance use disorder
8. current diagnosis of an eating disorder
9. current depressive or manic episode
10. diagnosis of a neurodevelopmental disorder
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)
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Kristen Mackiewicz Seghete, PhD
Phone: 503-494-4476
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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