Self-Management of Chronic Depressive Symptoms in Pregnancy

Study Overview
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Brief Summary
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This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. Ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.

Detailed Description
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The investigators longitudinal mixed-methods study will use a one-group repeated measures intervention design coupled with qualitative methods to provide a comprehensive view of the feasibility, acceptability, and preliminary effects of the MOMS intervention. Semi-structured interviews, recruitment and retention numbers, and participant logs will be used to evaluate feasibility and acceptability of the intervention (Specific Aim 1). Recently collected archival comparison group data from an existing study will be used to contribute to explorations of preliminary effects of the intervention by comparing longitudinal psychobehavioral data, birth weight data (Specific Aims 2 and 3).

Official Title
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Self-Management of Chronic Depressive Symptoms in Pregnancy

Conditions
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Depression

Intervention / Treatment
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* Behavioral: MOMS Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ age 18; self-report of depressive symptoms prior to pregnancy; current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the Patient Health Questionnaire-9; able to read, write, and understand English; self-identify as black/African American (AA) or White; absence of suicidal ideations (measured as low risk on the M.I.N.I. Neuropsychiatric Interview tool); absence of pregnancy complications/physical conditions making physical activity (PA) inadvisable; has not engaged in a consistent mindfulness-based PA routine during the pregnancy (such as yoga or similar activities more than once per month). Exclusion Criteria: If individual does not meet the inclusion criteria listed above, they are ineligible for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOMS Program<br>The MOMS Program involves: (1) mindfulness of symptoms and goal-setting through a nurse-participant partnership, and (2) 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home activity. Participants will engage in 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home practice. | Behavioral: MOMS Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # individuals who enrolled in study/ # individuals who expressed interest in the study | Recruitment data | Through study completion | 
| # of participants enrolled/ # of participants completing study | Retention data | Through study completion (end of 6-week postpartum visit) | 
| total # of minutes of yoga | Adherence to yoga aspect of intervention | End of 12 week intervention | 
| Semi-structured qualitative interviews | Participant satisfaction data | End of 6 week postpartum visit | 
| Edinburgh Postnatal Depression Scale (EPDS) | Pregnancy-specific Depressive Symptoms | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ9) | Depressive Symptoms | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| State-Trait Anxiety Inventory-State (STAI-S) | State Anxiety | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| Ruminations Response Scale (RRS-10) | Ruminations | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| Karitane Parenting Confidence Scale (KPCS) | Parenting Self-Efficacy | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| Maternal Fetal Attachment Scale (MFAS) | Maternal-Child Attachment | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| Baby's Birth Weight | per mother's report at 6-week postpartum visit | 6-week postpartum visit | 
| Perceived Stress Scale (PSS) | Stress | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| Physical Activity Self-Efficacy Scale (PASES) | Physical Activity Self-Efficacy | Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up | 
| total # of minutes in physical activity (including yoga) | Adherence to physical activity aspect of intervention (including yoga) | End of 12 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Self-Management, Yoga