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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41MH134692 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Center M | Experimental | This intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions. |
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| Treatment as Usual (TAU) | Active Comparator | This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Center M | Behavioral | Digital mental health platform. Screening and prevention activities will be provided through the Center M platform, telehealth group mindfulness sessions, and digitally delivered home practice materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Screening Rate | Rates of PD screening in Center M and TAU groups. | 6 weeks postpartum |
| PD Symptoms at baseline | PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS). | Initial screening pre-intervention |
| PD Symptoms post intervention | PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS). | Two weeks post intervention |
| PD Symptoms post intervention | PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS). | Four weeks post intervention |
| PD Symptoms postpartum | PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS). | Six weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8). | Six weeks postpartum |
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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 |
Deidentified data will be shared with IRB #17203 (MBCT-PD Feasibility) #19166 (The Roo Study on Mom and Baby Well-Being) #18579 (Prenatal Environment and Child Health), #19004 (Maternal Well-Being Study) or #20186 (Parents Engaging Infants Study or PENGuIN). This is included in the consent form. Data will be linked between studies using non-HIPAA based participant identification numbers. Any research staff transferring data will be included on all of the study IRB protocols.
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Data for specific participants who need to be linked across studies will be deidentified and transferred. Data is only accessible on an individual user basis by Principal Investigators. Any research staff transferring data will be included on all of the study IRB protocols.
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Behavioral | Paper screening and PD handout. |
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