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OpenTrials
Completed

NCT Number: NCT06000449

Center M: Digital Health Innovation Pilot

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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Key information

Conditions

Perinatal Depression

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Treatment as Usual

Behavioral

Paper screening and PD handout.

Primary outcomes

  1. Screening Rate

    Time frame: 6 weeks postpartum

    Rates of PD screening in Center M and TAU groups.

  2. PD Symptoms at baseline

    Time frame: 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).

  3. PD Symptoms post intervention

    Time frame: Two 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).

  4. PD Symptoms post intervention

    Time frame: 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).

  5. PD Symptoms postpartum

    Time frame: 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 outcomes

  1. Participant Satisfaction

    Time frame: Six weeks postpartum

    Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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