Official Title
Center M Randomized Trial
Brief Summary

This is a randomized controlled trial with an intervention of Center M compared totreatment as usual. Center M consists of weekly digital one-hour group sessions led by atrained therapist aligned with mindfulness based cognitive therapy. Changes in perinataldepression symptoms will be compared between groups.

Detailed Description

The study is a randomized control trial (RCT) with two parallel arms, 1) an intervention
arm: Center M added to treatment as usual (TAU), defined as standard prenatal care, and
2) a control arm: TAU, again defined as standard prenatal care. As both groups will be
obtaining services through the Center for Women's Health at OHSU, offered standard
prenatal care is expected to be similar in both arms. The study will be masked to the PI,
Co-I's, consultants, and anyone directly collecting or analyzing study data. Primary
prenatal care providers will also be masked to subject assignment. Participant and
interventionist masking is not possible due to the nature of the intervention arm. The
research coordinator(s), research assistants needing to communicate with research
participants about group activities (e.g., responding to logistical emails), and
volunteers who support the research coordinator or research assistants with
communications regarding groups will also be unmasked. Participants will be randomized by
the research coordinator or designated research assistant after eligibility determination
and study consent.

The Center M intervention proceeds sequentially with weekly one-hour group sessions led
by a trained, masters-level (or equivalent) therapist. Each group will include 3-6
participants. These sessions are conducted digitally via WebEx. Center M session
structure aligns with mindfulness based cognitive therapy by including: 1) introduction
of a core theme and rationale for how this theme relates to mental well-being (i.e.,
psychoeducation); 2) teaching core mindfulness (including an emphasis on self-compassion)
and CBT skills; 3) facilitating in-session practice of skills (i.e., experiential
learning); and 4) reviewing home practice of skills as well as barriers to practice.
Sessions are focused on skill development, both through active engagement in practice
during group sessions and individual home practice. Center M content teaches skills that
increase capability for effectively navigating general life stress and the unique
stresses of pregnancy and parenting. It is further designed to increase awareness of
early warning signs of perinatal depression to allow for identification of the need for
additional resources (including more intensive preventive intervention). The curriculum
is designed to be a 'light touch', or minimum necessary intervention that still retains
the capacity to prevent perinatal depression. Examples and summaries of the curriculum
and accompanying handouts and homework are outlined below and full curriculum, handouts,
and homework are available in the IRB documents. The Center M curriculum, handouts and
homework follows the parent model MBCT curriculum, with alterations made in direct
communication with Sona Dimidjian, PhD, and Sherryl Goodman, PhD, the developers of the
parent model. The Center M adaptation has been accomplished with the support and
involvement of Drs. Dimidjian and Goodman.

Not yet recruiting
Perinatal Depression

Behavioral: Center M

In addition to standard prenatal care, participants will participate in Center M
sessions, which are weekly one-hour digital group sessions led by a therapist. Each group
will include 3-6 participants. The Center M session structure aligns with
mindfulness-based cognitive therapy by including mental well-being, core mindfulness and
cognitive behavioral therapy skills, in-session practice of skills, and home practice
skills. Center M content teaches skills that increase capability for effectively
navigating general life stress and the unique stresses of pregnancy and parenting.
Other Name: Mindfulness Based Cognitive Therapy - Perinatal Depression

Eligibility Criteria

Inclusion Criteria:

- Currently pregnant at ≥ 12 weeks of gestation age (GA)

- ≤ 34 weeks GA at time of Center M intervention initiation

- Receiving prenatal care through the Center for Women's Health at Oregon Health &
Science University

- Able to fluently understand, speak and read English

- Available, able and willing to attend online group sessions

- Willing and able to receive home practice materials on an accessible smartphone,
tablet or computer

- Residing in Oregon or Washington

- Willingness to participate in either randomization arm

Exclusion Criteria:

- Current or past enrollment in a formal mindfulness-based intervention group

- Score in the "severe" range on the Edinburgh Postnatal Depression Scale (EPDS) (≥
20) or Patient History Questionnaire (PHQ-9) (≥ 20)

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Not Provided

John & Tami Marick Foundation
NCT Number
Keywords
mindfulness based cognitive therapy