Preventing Perinatal Depression

Center M Feasibility and Efficacy Pilot Study

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD).

Study Overview

• Status: Completed
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: Center M

Detailed Description

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD). Pregnant participants will be surveyed at three time points: pre-intervention, post-intervention, and 6-weeks postpartum. Surveys will include self-report measures evaluating depressive symptoms, mindfulness skills, emotion regulation, and participant satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• gestational age at intervention onset between 12 and 30 weeks
• English fluency
• no previous experience in a mindfulness-based intervention group
• ability and willingness to participate in a telehealth intervention

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Center M Intervention; Data from participants in this arm will be compared across pre-intervention, post-intervention, and 6-weeks postpartum. All participants will receive the Center M intervention, which includes group-based Cognitive Behavioral Therapy (CBT) sessions and home practice materials.

Behavioral: Center M; Center M consists of weekly, 1-hour, telehealth, mindfulness-based Cognitive Behavioral Therapy (CBT) group sessions for four consecutive weeks. Participants joined group sessions on their personal computer, tablet, or phone. Each visit involved the introduction of a core mental well-being theme, learning skills to develop non-judgmental self-awareness and/or cognitive reappraisal skills, skills practice, and discussion of home practice materials. Home practice materials included written mindful awareness instructions, audio-guided meditations, self-compassion exercises, and practices in recognizing the interrelationships between thoughts, feelings, and behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS)	10-item self-report measure used to assess perinatal depression symptomology over the past seven days.	Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
Patient Health Questionnaire - 8 (PHQ-8)	Self-report measure that assesses depressive symptoms over the past two weeks.	Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
Five Facets of Mindfulness Questionnaire (FFMQ)	39-item self-report measure to assess mindfulness skills.	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Emotional Regulation Questionnaire (ERQ)	10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression.	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERQ Cognitive Reappraisal Subscale	6 items to reflect cognitive reframing or restructuring.	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
ERQ Expressive Suppression Subscale	4 items to reflect expressive suppression.	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Center M Satisfaction	60 minute telehealth format focus groups including open-ended questions about their experience with Center M or two-question survey with a Likert scale satisfaction question and a free text question.	Post-intervention (within 1 week after last session)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Ellen Tilden, PhD, CNM, FACNM, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Prenatal Care; Maternal Mortality; Maternal Morbidity; Mindfulness-Based Cognitive Behavioral Therapy for Perinatal Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Infant, Newborn, Diseases; Depression; Depressive Disorder; Asphyxia Neonatorum
• Other Study ID Numbers: OHSU IRB 24818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No