Center M: Digital Health Innovation Pilot

Not Applicable

Recruiting

• Conditions: Perinatal Depression
• Interventions: Behavioral: Center M; Behavioral: Treatment as Usual

• Registration Number: NCT06000449
• Lead Sponsor: Oregon Health and Science University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2024-02-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Center M	Center M	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.
Treatment as Usual (TAU)	Treatment as Usual	This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.

Primary Outcome Measures

Name	Time	Method
Screening Rate	6 weeks postpartum	Rates of PD screening in Center M and TAU groups.
PD Symptoms at baseline	Initial screening pre-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).
PD Symptoms post intervention	Four weeks 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).
PD Symptoms postpartum	Six weeks 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).

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction	Six weeks postpartum	Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States