Center M: Digital Health Innovation Pilot

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Perinatal Depression

Treatments: Behavioral: Treatment as Usual; Behavioral: Center M

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06000449

STUDY00026642

1R41MH134692 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 116 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Center M

Experimental group

Description:

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:

Behavioral: Center M

Treatment as Usual (TAU)

Active Comparator group

Description:

This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.

Treatment:

Behavioral: Treatment as Usual