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

NCT05137925 | Completed

• 1 other identifier: STUDY21060191
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Distress; Pregnancy Related; Postpartum Blues; Postpartum Depression; Postpartum Anxiety; Postpartum Sadness

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Change in disinhibition from baseline to 8 weeks

  baseline and 8 weeks

• Change in disinhibition from 8 weeks to 3 months

  8 weeks and 3 months

• Change in attention from baseline to 8 weeks

  baseline and 8 weeks

• Change in attention from 8 weeks to 3 months

  8 weeks to 3 months

• Change in cognitive inflexibility from baseline to 8 weeks

  baseline to 8 weeks

Other Outcomes (4)

• Participant satisfaction at 3 months

  3 months

• Participant satisfaction at 8 weeks

  8 weeks

• Engagement (attendance) at 8 weeks

  8 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.

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.

Behavioral: Treatment as Usual (TAU)

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

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.

Mindfulness-Based Cognitive Therapy (MBCT)

Treatment as Usual (TAU) BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Psychological Foundation: collaborator
• The Pittsburgh Foundation: collaborator

Study Sites (1)

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michele Levine, PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Shannon Donofry, PhD

  University of Pittsburgh-Psychology and (primarily) AHN Psychiatry & Behavioral Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 30, 2021
• Study Start: September 1, 2023
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)