Perinatal DepressionNCT06525922
Preventing Perinatal Depression
A study testing Center M in people with Perinatal Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Center M
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Center M Feasibility and Efficacy Pilot 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).
Read the detailed description
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.
- Conditions
- Perinatal Depression
- Being tested
- Center M
- Keywords
- Prenatal Care, Mindfulness-Based Cognitive Behavioral Therapy for Perinatal Depression, Maternal Morbidity, Maternal Mortality
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center MBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Center M Intervention | Experimental | Data from participants in this arm will be compared across pre-intervention, post-intervention, and 6-weeks postpartum. All participants will receive the Center M intervention, which includes group-based Cognitive Behavioral Therapy (CBT) sessions and home practice materials. Receives: Behavioral: Center M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS)
10-item self-report measure used to assess perinatal depression symptomology over the past seven days.
Measured: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
Patient Health Questionnaire - 8 (PHQ-8)
Self-report measure that assesses depressive symptoms over the past two weeks.
Measured: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
Five Facets of Mindfulness Questionnaire (FFMQ)
39-item self-report measure to assess mindfulness skills.
Measured: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Emotional Regulation Questionnaire (ERQ)
10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression.
Measured: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Secondary outcomes (3)
ERQ Cognitive Reappraisal Subscale
6 items to reflect cognitive reframing or restructuring.
Measured: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
ERQ Expressive Suppression Subscale
4 items to reflect expressive suppression.
Measured: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Center M Satisfaction
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.
Measured: Post-intervention (within 1 week after last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start4 Aug 2021
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group was compared between pre-intervention and post-intervention time points.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Tilden, Oregon Health and Science University
- Investigators
- Ellen Tilden, PhD, CNM, FACNM, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525922
- Sponsor's protocol ID
- OHSU IRB 24818
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center M Feasibility and Efficacy Pilot Study
- ClinicalTrials.gov ID
- NCT06525922
- Acronym / sponsor ID
- OHSU IRB 24818
- Conditions
- Perinatal Depression
- Keywords
- Prenatal Care, Mindfulness-Based Cognitive Behavioral Therapy for Perinatal Depression, Maternal Morbidity, Maternal Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group was compared between pre-intervention and post-intervention time points.
| Arm | Type | Receives |
|---|---|---|
| Center M Intervention | Experimental | Behavioral: Center MData from participants in this arm will be compared across pre-intervention, post-intervention, and 6-weeks postpartum. All participants will receive the Center M intervention, which includes group-based Cognitive Behavioral Therapy (CBT) sessions and home practice materials. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center MCenter 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. | Behavioural | Center M Intervention |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
ERQ Cognitive Reappraisal Subscale
Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
ERQ Expressive Suppression Subscale
Time frame: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Center M Satisfaction
Time frame: Post-intervention (within 1 week after last session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Perinatal Depression
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Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
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Preeclampsia Research on Vitamin D, Inflammation, & Depression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Tilden, PhD, CNM, FACNM principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center M in people with Perinatal Depression, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.