Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness-Based Cognitive Therapy (MBCT)
MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.
  • 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.
Active Comparator
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.
  • 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Michele Levine, PhD
4126470703
levinem@upmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.