Preventing Perinatal Depression

NCT06525922 | Completed

• 1 other identifier: OHSU IRB 24818
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Perinatal Depression

Keywords

Prenatal Care; Mindfulness-Based Cognitive Behavioral Therapy for Perinatal Depression; Maternal Morbidity; Maternal Mortality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• ERQ Cognitive Reappraisal Subscale

  Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

• ERQ Expressive Suppression Subscale

  Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

• Center M Satisfaction

  Post-intervention (within 1 week after last session)

Study Arms (1)

Center M Intervention

EXPERIMENTAL

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

Interventions

Center M BEHAVIORAL

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.

Center M Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Tilden, PhD, CNM, FACNM

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group was compared between pre-intervention and post-intervention time points.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 29, 2024
• Study Start: August 4, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)