Clinical trial NCT06525922: Preventing Perinatal Depression
Official title: Center M Feasibility and Efficacy Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: Prenatal Care
Mindfulness-Based Cognitive Behavioral Therapy for Perinatal Depression
Maternal Morbidity
Maternal Mortality
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group was compared between pre-intervention and post-intervention time points.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
measure: Patient Health Questionnaire - 8 (PHQ-8)
timeFrame: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Secondary outcomes:
measure: ERQ Cognitive Reappraisal Subscale
timeFrame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
measure: ERQ Expressive Suppression Subscale
timeFrame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
measure: Center M Satisfaction
timeFrame: Post-intervention (within 1 week after last session)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ellen Tilden, PhD, CNM, FACNM
role: PRINCIPAL_INVESTIGATOR
References: