Psychological DistressNCT05137925
Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Treatment as Usual (TAU) in people with Psychological Distress and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
Trial summary
The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Pregnancy Related, Postpartum Blues
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnancy between 12 and 30 weeks gestation
- reporting at least mild psychological distress (based on self-report)
- access to high-speed internet or cellular network access
- located in the U.S.
Who cannot join
- current suicidal or homicidal ideation as assessed verbally during screening
- symptom severity necessitating a higher level of clinical care
- current psychosis
- untreated mania
- active substance abuse
- lack of high-speed internet connection or cellular network access
- planning to be traveling without access to internet for more than two weeks in the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Exploring Mechanisms of Change in a Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy to Promote Well-being During Pregnancy and Postpartum Among At-risk Pregnant Women
The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.
Read the detailed description
Pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why MBCT improves psychological health during the perinatal period. Thus, the goals of this project are to (1) examine whether MBCT improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of MBCT, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.
- Conditions
- Psychological Distress, Pregnancy Related, Postpartum Blues, Postpartum Depression, Postpartum Anxiety, Postpartum Sadness
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT), Treatment as Usual (TAU)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
MBCT is an 8-week group-based treatment modality designed specifically to prevent recurrence of depressive symptoms. MBCT combines principles of cognitive behavioral therapy and mindfulness meditation to help participants change the way in which they relate to automatic negative thinking patterns that trigger symptom recurrence. Through awareness and acceptance of negative thoughts and emotions, participants learn how to dismiss negative thoughts and to tolerate distress and uncertainty.
Treatment as Usual (TAU)Behavioural
TAU (the control group) provides participants with information about the benefits of mindfulness in pregnancy and offers referrals for psychotherapy in the community. Participants in TAU are contacted monthly via phone or videoconference call to maintain engagement.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week. Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| Treatment as Usual (TAU) | Active comparator | TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in presence and severity of depressive symptoms from baseline to 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.
Measured: baseline and 8 weeks
Change in presence and severity of depressive symptoms from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in perceptions of daily life stress from baseline to 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.
Measured: baseline and 8 weeks
Change in perceptions of daily life stress from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in anxiety symptoms from baseline to 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.
Measured: baseline and 8 weeks
Change in anxiety symptoms from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in rumination from baseline to 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.
Measured: baseline and 8 weeks
Change in rumination from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in mindfulness from baseline to 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.
Measured: baseline and 8 weeks
Change in mindfulness from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in rates of psychiatric diagnoses from baseline to 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.
Measured: baseline and 3 months
Secondary outcomes (8)
Change in disinhibition from baseline to 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.
Measured: baseline and 8 weeks
Change in disinhibition from 8 weeks to 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.
Measured: 8 weeks and 3 months
Change in attention from baseline to 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.
Measured: baseline and 8 weeks
Change in attention from 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.
Measured: 8 weeks to 3 months
Change in cognitive inflexibility from 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.
Measured: baseline to 8 weeks
Change in cognitive inflexibility from 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.
Measured: 8 weeks to 3 months
Change in emotion regulation from baseline to 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.
Measured: baseline and 8 weeks
Change in emotion regulation from 8 weeks to 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.
Measured: 8 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Sep 2023
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study will randomize participants to an eight-week virtual group-based Mindfulness-based Cognitive Therapy intervention or to a treatment as usual control condition.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, The Pittsburgh Foundation
- Responsible party
- Principal investigator, Michele Levine, University of Pittsburgh
- Investigators
- Michele Levine, PhD, Principal investigator, University of Pittsburgh Medical CenterShannon Donofry, PhD, Principal investigator, University of Pittsburgh-Psychology and (primarily) AHN Psychiatry & Behavioral Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137925
- Sponsor's protocol ID
- STUDY21060191
- Status last verified
- Mar 2026
- First submitted
- 26 Oct 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans and no requirements to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mechanisms of Change in a Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy to Promote Well-being During Pregnancy and Postpartum Among At-risk Pregnant Women
- ClinicalTrials.gov ID
- NCT05137925
- Acronym / sponsor ID
- STUDY21060191
- Conditions
- Psychological Distress, Pregnancy Related, Postpartum Blues, Postpartum Depression, Postpartum Anxiety, Postpartum Sadness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Psychological Foundation, The Pittsburgh Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.
Detailed description
Pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why MBCT improves psychological health during the perinatal period. Thus, the goals of this project are to (1) examine whether MBCT improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of MBCT, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study will randomize participants to an eight-week virtual group-based Mindfulness-based Cognitive Therapy intervention or to a treatment as usual control condition.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnancy between 12 and 30 weeks gestation
- reporting at least mild psychological distress (based on self-report)
- access to high-speed internet or cellular network access
- located in the U.S.
Key exclusion criteria (7 listed)
- current suicidal or homicidal ideation as assessed verbally during screening
- symptom severity necessitating a higher level of clinical care
- current psychosis
- untreated mania
- active substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT)MBCT is an 8-week group-based treatment modality designed specifically to prevent recurrence of depressive symptoms. MBCT combines principles of cognitive behavioral therapy and mindfulness meditation to help participants change the way in which they relate to automatic negative thinking patterns that trigger symptom recurrence. Through awareness and acceptance of negative thoughts and emotions, participants learn how to dismiss negative thoughts and to tolerate distress and uncertainty. | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) |
| Treatment as Usual (TAU)TAU (the control group) provides participants with information about the benefits of mindfulness in pregnancy and offers referrals for psychotherapy in the community. Participants in TAU are contacted monthly via phone or videoconference call to maintain engagement. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in presence and severity of depressive symptoms from baseline to 8 weeks
Time frame: 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.
Change in presence and severity of depressive symptoms from 8 weeks to 3 months
Time frame: 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.
Change in perceptions of daily life stress from baseline to 8 weeks
Time frame: 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.
Change in perceptions of daily life stress from 8 weeks to 3 months
Time frame: 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.
Change in anxiety symptoms from baseline to 8 weeks
Time frame: 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.
Change in anxiety symptoms from 8 weeks to 3 months
Time frame: 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.
Change in rumination from baseline to 8 weeks
Time frame: 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.
Change in rumination from 8 weeks to 3 months
Time frame: 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.
Change in mindfulness from baseline to 8 weeks
Time frame: 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.
Change in mindfulness from 8 weeks to 3 months
Time frame: 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.
Change in rates of psychiatric diagnoses from baseline to 3 months
Time frame: 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.
8 secondary outcomes
Change in disinhibition from baseline to 8 weeks
Time frame: baseline and 8 weeks
Change in disinhibition from 8 weeks to 3 months
Time frame: 8 weeks and 3 months
Change in attention from baseline to 8 weeks
Time frame: baseline and 8 weeks
Change in attention from 8 weeks to 3 months
Time frame: 8 weeks to 3 months
Change in cognitive inflexibility from baseline to 8 weeks
Time frame: baseline to 8 weeks
Change in cognitive inflexibility from 8 weeks to 3 months
Time frame: 8 weeks to 3 months
Change in emotion regulation from baseline to 8 weeks
Time frame: baseline and 8 weeks
Change in emotion regulation from 8 weeks to 3 months
Time frame: 8 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. There are no plans and no requirements to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Levine, PhD principal investigator
University of Pittsburgh Medical Center
Shannon Donofry, PhD principal investigator
University of Pittsburgh-Psychology and (primarily) AHN Psychiatry & Behavioral Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Treatment as Usual (TAU) in people with Psychological Distress and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in presence and severity of depressive symptoms from baseline to 8 weeks (time frame: baseline and 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.