Preventing Perinatal Depression

Not Applicable

Completed

• Conditions: Perinatal Depression
• Interventions: Behavioral: Center M

• Registration Number: NCT06525922
• Lead Sponsor: Oregon Health and Science University

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).

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 Timeline

• Study Start: 2021-08-04
• Primary Completion: 2024-03-13
• Study Completion: 2024-03-13
• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Center M Intervention	Center M	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ERQ Cognitive Reappraisal Subscale	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum	6 items to reflect cognitive reframing or restructuring.
ERQ Expressive Suppression Subscale	Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum	4 items to reflect expressive suppression.
Center M Satisfaction	Post-intervention (within 1 week after last session)	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States