Clinical trial NCT05137925: Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychological Distress
Pregnancy Related
Postpartum Blues
Postpartum Depression
Postpartum Anxiety
Postpartum Sadness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
name: The Pittsburgh Foundation
First posted: 2021-11-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in presence and severity of depressive symptoms from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in presence and severity of depressive symptoms from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in perceptions of daily life stress from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in perceptions of daily life stress from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in anxiety symptoms from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in anxiety symptoms from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in rumination from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in rumination from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in mindfulness from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in mindfulness from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in rates of psychiatric diagnoses from baseline to 3 months
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Change in disinhibition from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in disinhibition from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
measure: Change in attention from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in attention from 8 weeks to 3 months
timeFrame: 8 weeks to 3 months
measure: Change in cognitive inflexibility from baseline to 8 weeks
timeFrame: baseline to 8 weeks
measure: Change in cognitive inflexibility from 8 weeks to 3 months
timeFrame: 8 weeks to 3 months
measure: Change in emotion regulation from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in emotion regulation from 8 weeks to 3 months
timeFrame: 8 weeks and 3 months
Other outcomes:
measure: Participant satisfaction at 3 months
timeFrame: 3 months
measure: Participant satisfaction at 8 weeks
timeFrame: 8 weeks
measure: Engagement (attendance) at 8 weeks
timeFrame: 8 weeks
measure: Engagement (homework) at 8 weeks
timeFrame: 8 weeks
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute & Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Michele Levine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh-Psychology and (primarily) AHN Psychiatry & Behavioral Health Institute
name: Shannon Donofry, PhD
role: PRINCIPAL_INVESTIGATOR
References: