Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum
NCT05137925, Not applicable, Completed, University of Pittsburgh
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum | ClinicalTrials.gov |
| NCT number | NCT05137925 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 84 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Pittsburgh | ClinicalTrials.gov |
| Conditions | Psychological Distress, Pregnancy Related, Postpartum Blues, Postpartum Depression, Postpartum Anxiety, Postpartum Sadness | ClinicalTrials.gov |
| Interventions | Mindfulness-Based Cognitive Therapy (MBCT), Treatment as Usual (TAU) | ClinicalTrials.gov |
| First posted | 2021-11-30 | ClinicalTrials.gov |
| Last updated | 2026-03-04 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in presence and severity of depressive symptoms from baseline to 8 weeks | baseline and 8 weeks | Change in the presence and severity of depressive symptoms from baseline to 8 weeks will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression. | ClinicalTrials.gov |
| Primary | Change in presence and severity of depressive symptoms from 8 weeks to 3 months | 8 weeks and 3 months | Change in the presence and severity of depressive symptoms from baseline to 3 months will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression. | ClinicalTrials.gov |
| Primary | Change in perceptions of daily life stress from baseline to 8 weeks | baseline and 8 weeks | Change in the perceptions of daily life stress from baseline to 8 weeks will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress. | ClinicalTrials.gov |
| Primary | Change in perceptions of daily life stress from 8 weeks to 3 months | 8 weeks and 3 months | Change in the perceptions of daily life stress from 8 weeks to 3 months will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress. | ClinicalTrials.gov |
| Primary | Change in anxiety symptoms from baseline to 8 weeks | baseline and 8 weeks | Change in anxiety symptoms from baseline to 8 weeks will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry. | ClinicalTrials.gov |
| Primary | Change in anxiety symptoms from 8 weeks to 3 months | 8 weeks and 3 months | Change in anxiety symptoms from 8 weeks to 3 months will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry. | ClinicalTrials.gov |
| Primary | Change in rumination from baseline to 8 weeks | baseline and 8 weeks | Change in rumination from baseline to 8 weeks will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination. | ClinicalTrials.gov |
| Primary | Change in rumination from 8 weeks to 3 months | 8 weeks and 3 months | Change in rumination from 8 weeks to 3 months will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination. | ClinicalTrials.gov |
| Primary | Change in mindfulness from baseline to 8 weeks | baseline and 8 weeks | Change in mindfulness from baseline to 8 weeks will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness. | ClinicalTrials.gov |
| Primary | Change in mindfulness from 8 weeks to 3 months | 8 weeks and 3 months | Change in mindfulness from 8 weeks to 3 months will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness. | ClinicalTrials.gov |
| Primary | Change in rates of psychiatric diagnoses from baseline to 3 months | baseline and 3 months | Change in rates of psychiatric diagnoses from baseline to 3 months will be measured using the Structured Clinical Interview for DSM-5 (SCID-5). The SCID-5 consists of a semistructured interview administered to participants by a clinician or trained mental health professional to determine participants' current and previous psychiatric diagnoses. | ClinicalTrials.gov |
| Secondary | Change in disinhibition from baseline to 8 weeks | baseline and 8 weeks | Change in disinhibition from baseline to 8 weeks will be assessed by the Go/No-Go task (GNG). The GNG task is administered on the computer and asks participants to respond to visual stimuli that is presented continuously. Participants must make a motor response for the "go" stimulus and withhold a motor response for the "no-go" stimulus. The proportion of no-go targets in which an individual successfully withholds a motor response will provide a measure of response inhibition, with fewer errors indicating better response inhibition and a higher error rate indicating a greater tendency towards disinhibited behavior. | ClinicalTrials.gov |
| Secondary | Change in disinhibition from 8 weeks to 3 months | 8 weeks and 3 months | Change in disinhibition from 8 weeks to 3 months will be assessed by the Go/No-Go task (GNG). The GNG task is administered on the computer and asks participants to respond to visual stimuli that is presented continuously. Participants must make a motor response for the "go" stimulus and withhold a motor response for the "no-go" stimulus. The proportion of no-go targets in which an individual successfully withholds a motor response will provide a measure of response inhibition, with fewer errors indicating better response inhibition and a higher error rate indicating a greater tendency towards disinhibited behavior. | ClinicalTrials.gov |
| Secondary | Change in attention from baseline to 8 weeks | baseline and 8 weeks | Change in attention from baseline to 8 weeks will be assessed by the Stroop Color-Word Test. The Stroop Color-Word Test is a computerized task in which participants are required to name the color of a written color word while inhibiting the impulse to read the word itself. The difference between mean response times of correct responses on incongruent and control trials is used to compute an interference score, which provides a measure of attention, with lower scores indicating greater attentional deficits. | ClinicalTrials.gov |
| Secondary | Change in attention from 8 weeks to 3 months | 8 weeks to 3 months | Change in attention from 8 weeks to 3 months will be assessed by the Stroop Color-Word Test. The Stroop Color-Word Test is a computerized task in which participants are required to name the color of a written color word while inhibiting the impulse to read the word itself. The difference between mean response times of correct responses on incongruent and control trials is used to compute an interference score, which provides a measure of attention, with lower scores indicating greater attentional deficits. | ClinicalTrials.gov |
| Secondary | Change in cognitive inflexibility from baseline to 8 weeks | baseline to 8 weeks | Change in cognitive inflexibility from baseline to 8 weeks will be assessed by the Wisconsin Card Sorting Task (WCST). The WCST is a computerized task in which participants have to match a target card with one of four category cards under changing conditions. The number of incorrect responses that would have been correct for the preceding condition provides a measure of cognitive inflexibility, with higher scores indicating greater cognitive inflexibility. | ClinicalTrials.gov |
| Secondary | Change in cognitive inflexibility from 8 weeks to 3 months | 8 weeks to 3 months | Change in cognitive inflexibility from 8 weeks to 3 months will be assessed by the Wisconsin Card Sorting Task (WCST). The WCST is a computerized task in which participants have to match a target card with one of four category cards under changing conditions. The number of incorrect responses that would have been correct for the preceding condition provides a measure of cognitive inflexibility, with higher scores indicating greater cognitive inflexibility. | ClinicalTrials.gov |
| Secondary | Change in emotion regulation from baseline to 8 weeks | baseline and 8 weeks | Change in emotion regulation from baseline to 8 weeks will be measured using the 10-item Emotion Regulation Questionnaire (ERQ). The ERQ consists of two subscales, which are calculated by summing the following questions, which are scored 1-7 (none reverse scored): cognitive reappraisal = questions 1, 3, 5, 7, 8, and 10; expressive suppression = questions 2, 4, 6, and 9. For the ERQ subscales, scores can range from 1-42, with higher scores indicating higher use of that particular emotion regulation strategy and lower scores indicating less frequent use. | ClinicalTrials.gov |
| Secondary | Change in emotion regulation from 8 weeks to 3 months | 8 weeks and 3 months | Change in emotion regulation from 8 weeks to 3 months will be measured using the 10-item Emotion Regulation Questionnaire (ERQ). The ERQ consists of two subscales, which are calculated by summing the following questions, which are scored 1-7 (none reverse scored): cognitive reappraisal = questions 1, 3, 5, 7, 8, and 10; expressive suppression = questions 2, 4, 6, and 9. For the ERQ subscales, scores can range from 1-42, with higher scores indicating higher use of that particular emotion regulation strategy and lower scores indicating less frequent use. | ClinicalTrials.gov |
| Other | Participant satisfaction at 3 months | 3 months | Participant satisfaction at 3 months will be measured quantitively with a 7-item Client Satisfaction Questionnaire (CSQ). Questions 1-3 on the CSQ assess participants' treatment satisfaction using a 10-point Likert scale. Questions 4-7 are opened-ended questions where participants can elaborate on their satisfaction with the treatment. Scores on questions 1-3 will be used to evaluate participant satisfaction and can range from 1-10. Total scores are calculated by summing the scores on questions 1-3 and can range from 3-30, with higher scores indicating greater participant satisfaction. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
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 |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary 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)