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Center M Randomized Trial

ConditionPerinatal Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOregon Health and Science University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Center M

    Behavioral

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Center MExperimental treatment 1 intervention
Group B: Treatment as Usual (TAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in EPDS scores (baseline to 6 weeks)

Measured by the Edinburgh Postnatal Depression Scale (EPDS). EPDS is scored on a scale from 0 to 30 with higher scores representing more symptoms of depression.

Time frame
Difference between baseline and 6 weeks postpartum
2

Change in PHQ scores (baseline to 6 weeks)

Measured by the Patient Health Questionnaire (PHQ-9). PHQ-9 is scored on a scale from 0 to 27 with higher scores representing more symptoms of depression.

Time frame
Difference between baseline and 6 weeks postpartum

Secondary outcomes

1

Change in EPDS scores (baseline to 3 months)

Measured by the Edinburgh Postnatal Depression Scale (EPDS). EPDS is scored on a scale from 0 to 30 with higher scores representing more symptoms of depression.

Time frame
Difference between baseline and 3 months postpartum
2

Change in PHQ scores (baseline to 3 months)

Measured by the Patient Health Questionnaire (PHQ-9). PHQ-9 is scored on a scale from 0 to 27 with higher scores representing more symptoms of depression.

Time frame
Difference between baseline and 3 months postpartum
3

Change in Mindfulness

Measured by the Five Facet Mindfulness Questionnaire (FFMQ). Average total score can be between 1 and 5 with 5 representing the highest level of mindfulness.

Time frame
Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.
4

Change in Emotional Regulation

Measured by the Emotional Regulation Questionnaire (ERQ). It consists of two subscales, reappraisal and suppression. For the reappraisal subscale, scores can be between 6 and 42 with higher scores representing a more positive outcome. For the suppression subscale, scores can be between 4 and 28 with a higher score representing a worse outcome.

Time frame
Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

John & Tami Marick Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: