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

NCT ID: NCT05137925

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Cognitive Therapy (MBCT)

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

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

American Psychological Foundation

OTHER

Sponsor Role: collaborator

The Pittsburgh Foundation

OTHER

Sponsor Role: collaborator

Responsible Party

Michele Levine

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Levine, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Shannon Donofry, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY21060191

Identifier Type: -

Identifier Source: org_study_id