Center M Feasibility and Efficacy Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Perinatal Depression
- Sponsor
- Oregon Health and Science University
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Edinburgh Postnatal Depression Scale (EPDS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ellen Tilden
Principal Investigator
Oregon Health and Science University
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
- Not provided
Outcomes
Primary Outcomes
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- ERQ Expressive Suppression Subscale(Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum)
- ERQ Cognitive Reappraisal 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))