Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137925
• Other study ID #: STUDY21060191
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Michele Levine, PhD
• Phone: 4126470703
• Email: levinem[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression, Postpartum
• Postpartum Anxiety
• Postpartum Blues
• Postpartum Depression
• Postpartum Sadness
• Pregnancy Related
• Psychological Distress

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	American Psychological Foundation, The Pittsburgh Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant satisfaction at 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.	3 months
Other	Participant satisfaction at 8 weeks	Participant satisfaction will be measured qualitatively with brief qualitative interviews performed at the end of the intervention, during which participants will have the opportunity to comment on their experiences in the group in an open-ended format. Responses during the interview will be recorded and evaluated using a thematic analysis.	8 weeks
Other	Engagement (attendance) at 8 weeks	Engagement will be measured by session attendance rates. Attending 4 of the 8 group sessions is will be considered completion of the intervention and, thus, sufficient engagement.	8 weeks
Other	Engagement (homework) at 8 weeks	Engagement will be assessed by the completion of daily homework as indicated by homework logs. Participants will be asked to practice mindfulness three days per week during the intervention period and will record the duration and type of meditation completed each day. Space will also be provided for participants to make note of anything they noticed about their practice. More frequent practice of mindfulness per week indicates higher levels of engagement.	8 weeks
Primary	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.	baseline and 8 weeks
Primary	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.	8 weeks and 3 months
Primary	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.	baseline and 8 weeks
Primary	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.	8 weeks and 3 months
Primary	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.	baseline and 8 weeks
Primary	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.	8 weeks and 3 months
Primary	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.	baseline and 8 weeks
Primary	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.	8 weeks and 3 months
Primary	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.	baseline and 8 weeks
Primary	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.	8 weeks and 3 months
Primary	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.	baseline and 3 months
Secondary	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.	baseline and 8 weeks
Secondary	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.	8 weeks and 3 months
Secondary	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.	baseline and 8 weeks
Secondary	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.	8 weeks to 3 months
Secondary	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.	baseline to 8 weeks
Secondary	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.	8 weeks to 3 months
Secondary	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.	baseline and 8 weeks
Secondary	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.	8 weeks and 3 months