Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy (NCT03809572) | Clinical Trial Compass
TerminatedNot Applicable
Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
Stopped: Due to restrictions to in-person research due to COVID-19
United States56 participantsStarted 2019-03-22
Plain-language 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.
Who can participate
Age range
21 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
. 21-45 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).
Exclusion criteria
. Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
Timeframe: 6 Weeks Postpartum
2
Emotion Regulation Questionnaire (ERQ)
Timeframe: 6 Weeks Postpartum
3
Stroop Task
Timeframe: 6 Weeks Postpartum
4
Brain activation during an emotion regulation task