Center M: Digital Health Innovation Pilot

Study Overview
=================
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).

Official Title
-----------------
Center M: Digital Health Innovation Pilot

Conditions
-----------------
Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: Center M
* Behavioral: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Center M<br>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. | Behavioral: Center M<br>* 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.<br>|
| Active Comparator: Treatment as Usual (TAU)<br>This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout. | Behavioral: Treatment as Usual<br>* Paper screening and PD handout.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction | Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8). | Six weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maternal Mental Health, Telehealth