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Completed

NCT Number: NCT06525922

Preventing Perinatal Depression

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD).

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Key information

Conditions

Perinatal Depression Death Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms

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

About this study

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD). Pregnant participants will be surveyed at three time points: pre-intervention, post-intervention, and 6-weeks postpartum. Surveys will include self-report measures evaluating depressive symptoms, mindfulness skills, emotion regulation, and participant satisfaction.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • gestational age at intervention onset between 12 and 30 weeks
  • English fluency
  • no previous experience in a mindfulness-based intervention group
  • ability and willingness to participate in a telehealth intervention

Exclusion criteria

-

Treatment and study plan

Center M

Behavioral

Center M consists of weekly, 1-hour, telehealth, mindfulness-based Cognitive Behavioral Therapy (CBT) group sessions for four consecutive weeks. Participants joined group sessions on their personal computer, tablet, or phone. Each visit involved the introduction of a core mental well-being theme, learning skills to develop non-judgmental self-awareness and/or cognitive reappraisal skills, skills practice, and discussion of home practice materials. Home practice materials included written mindful awareness instructions, audio-guided meditations, self-compassion exercises, and practices in recognizing the interrelationships between thoughts, feelings, and behaviors.

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum

    10-item self-report measure used to assess perinatal depression symptomology over the past seven days.

  2. Patient Health Questionnaire - 8 (PHQ-8)

    Time frame: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum

    Self-report measure that assesses depressive symptoms over the past two weeks.

  3. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

    39-item self-report measure to assess mindfulness skills.

  4. Emotional Regulation Questionnaire (ERQ)

    Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

    10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression.

Secondary outcomes

  1. ERQ Cognitive Reappraisal Subscale

    Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

    6 items to reflect cognitive reframing or restructuring.

  2. ERQ Expressive Suppression Subscale

    Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum

    4 items to reflect expressive suppression.

  3. Center M Satisfaction

    Time frame: Post-intervention (within 1 week after last session)

    60 minute telehealth format focus groups including open-ended questions about their experience with Center M or two-question survey with a Likert scale satisfaction question and a free text question.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Center M Feasibility and Efficacy Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

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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