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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ERQ Cognitive Reappraisal Subscale | 6 items to reflect cognitive reframing or restructuring. | Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum |
| ERQ Expressive Suppression Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Tilden, PhD, CNM, FACNM | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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One group was compared between pre-intervention and post-intervention time points.
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4 items to reflect expressive suppression.
| Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum |
| Center M Satisfaction | 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. | Post-intervention (within 1 week after last session) |