Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03809572|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Maternal Psychological Distress Postpartum Depression Prenatal Stress||Behavioral: Mindfulness Based Cognitive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Given the use of group therapy, participants and interventionists cannot be blinded to group assignment. The study is designed to minimize the extent to which study staff, aside from interventionists and the primary Study Coordinator(s), are aware of group assignment. The Study Coordinator(s) needs to know group assignment because they will inform participants of their group assignment and will be the main point of contact for participants throughout the study, as to reduce risk of participants revealing their group assignment to other study staff. Participants will be informed that only the Study Coordinator(s) and interventionists, if applicable, are aware of their group assignment. Therefore, in order to ensure the integrity of the research study, they should refrain from discussing their group assignment with other staff members.|
|Official Title:||Mechanisms of Action of MBCT-PD: A Pilot Study|
|Estimated Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Mindfulness Based Cognitive Therapy
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.
Behavioral: Mindfulness Based Cognitive Therapy
See Arm description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
No Intervention: Treatment as usual (TAU)
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.
- Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) [ Time Frame: 6 Weeks Postpartum ]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.
- Emotion Regulation Questionnaire (ERQ) [ Time Frame: 6 Weeks Postpartum ]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.
- Stroop Task [ Time Frame: 6 Weeks Postpartum ]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.
- Brain activation during an emotion regulation task [ Time Frame: 6 Weeks Postpartum ]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.
- Brain activation during the Stroop task [ Time Frame: 6 Weeks Postpartum ]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.
- Rate of Postpartum Depression [ Time Frame: 6 Weeks Postpartum, 6 Months Postpartum ]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).
- Emotion Regulation Questionnaire (ERQ) [ Time Frame: 6 Months Postpartum ]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.
- Stroop Task [ Time Frame: 6 Months Postpartum ]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.
- Infant Behavior Questionnaire - Revised (IBQ-R) [ Time Frame: 6 Months Postpartum ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809572
|Contact: Evelyn Jackson, BAfirstname.lastname@example.org|
|Contact: Olivia Doyle, BAemail@example.com|
|United States, Oregon|
|Oregon Health and Science University||Not yet recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Evelyn Jackson, BA 503-494-4476 firstname.lastname@example.org|
|Contact: Olivia Doyle, BA 5034181898 email@example.com|
|Principal Investigator: Kristen Mackiewicz Seghete, PhD|
|Sub-Investigator: Alice Graham, PhD|
|Sub-Investigator: Jodi Lapidus, PhD|
|Principal Investigator:||Kristen Mackiewicz Seghete, PhD||Oregon Health and Science University|