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

University of Pittsburgh

Status: Active, not recruiting

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

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05137925

STUDY21060191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy (MBCT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Treatment as Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment as Usual (TAU)