Center M: Digital Health Innovation Pilot

Perinatal Depression Clinical Trial

Official title:

Center M: Digital Health Innovation Pilot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000449
• Other study ID #: OHSU IRB 24818
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: August 2023
• Source: Oregon Health and Science University
• Contact: Kristen Mackiewicz Seghete, PhD
• Phone: 503-494-3029
• Email: mackiewi[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Currently pregnant

• Age 18-50 years

• Fluent in English

• Available and able to attend online group scheduled meetings

Exclusion Criteria:

• Current or past enrollment in a mindfulness-based intervention group

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

Intervention

Behavioral:
• Center M
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.
• Treatment as Usual
Paper screening and PD handout.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening Rate	Rates of PD screening in Center M and TAU groups.	6 weeks postpartum
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Participant Satisfaction	Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).	Six weeks postpartum