Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
NCT03809572, Not applicable, Terminated, Oregon Health and Science University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy | ClinicalTrials.gov |
| NCT number | NCT03809572 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 56 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Oregon Health and Science University | ClinicalTrials.gov |
| Conditions | Maternal Psychological Distress, Postpartum Depression, Prenatal Stress | ClinicalTrials.gov |
| Interventions | Mindfulness Based Cognitive Therapy | ClinicalTrials.gov |
| First posted | 2019-01-18 | ClinicalTrials.gov |
| Last updated | 2021-12-20 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) | 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. | ClinicalTrials.gov |
| Primary | Emotion Regulation Questionnaire (ERQ) | 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. | ClinicalTrials.gov |
| Primary | Stroop Task | 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. | ClinicalTrials.gov |
| Primary | Brain activation during an emotion regulation task | 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. | ClinicalTrials.gov |
| Primary | Brain activation during the Stroop task | 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. | ClinicalTrials.gov |
| Secondary | Rate of Postpartum Depression | 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). | ClinicalTrials.gov |
| Secondary | Emotion Regulation Questionnaire (ERQ) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Task | 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. | ClinicalTrials.gov |
| Secondary | Infant Behavior Questionnaire - Revised (IBQ-R) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 26654212 | BACKGROUND | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R21AT010292 | Mechanisms of Action of MBCT-PD: A Pilot Study | MACKIEWICZ SEGHETE, KRISTEN L | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2018 to 2019 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotion Regulation Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)