Skip to content

Preventing Perinatal Depression

Center M Feasibility and Efficacy Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06525922
Enrollment
87
Registered
2024-07-29
Start date
2021-08-04
Completion date
2024-03-13
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Depression

Keywords

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

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.

Interventions

BEHAVIORALCenter 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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
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 postpartum10-item self-report measure used to assess perinatal depression symptomology over the past seven days.
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 postpartumSelf-report measure that assesses depressive symptoms over the past two weeks.
Five Facets of Mindfulness Questionnaire (FFMQ)Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum39-item self-report measure to assess mindfulness skills.
Emotional Regulation Questionnaire (ERQ)Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression.

Secondary

MeasureTime frameDescription
ERQ Expressive Suppression SubscaleMeasured at pre-intervention (within 1 week before first session) and 6-weeks postpartum4 items to reflect expressive suppression.
Center M SatisfactionPost-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.
ERQ Cognitive Reappraisal SubscaleMeasured at pre-intervention (within 1 week before first session) and 6-weeks postpartum6 items to reflect cognitive reframing or restructuring.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026