Self-Management of Chronic Depressive Symptoms in Pregnancy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MOMS Program 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
|
Outcome Measures
Primary Outcome Measures
- # individuals who enrolled in study/ # individuals who expressed interest in the study [Through study completion]
Recruitment data
- # of participants enrolled/ # of participants completing study [Through study completion (end of 6-week postpartum visit)]
Retention data
- total # of minutes of yoga [End of 12 week intervention]
Adherence to yoga aspect of intervention
- Semi-structured qualitative interviews [End of 6 week postpartum visit]
Participant satisfaction data
- Edinburgh Postnatal Depression Scale (EPDS) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Pregnancy-specific Depressive Symptoms
Secondary Outcome Measures
- Patient Health Questionnaire-9 (PHQ9) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Depressive Symptoms
- State-Trait Anxiety Inventory-State (STAI-S) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
State Anxiety
- Ruminations Response Scale (RRS-10) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Ruminations
- Karitane Parenting Confidence Scale (KPCS) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Parenting Self-Efficacy
- Maternal Fetal Attachment Scale (MFAS) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Maternal-Child Attachment
- Baby's Birth Weight [6-week postpartum visit]
per mother's report at 6-week postpartum visit
- Perceived Stress Scale (PSS) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Stress
- Physical Activity Self-Efficacy Scale (PASES) [Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up]
Physical Activity Self-Efficacy
- total # of minutes in physical activity (including yoga) [End of 12 week intervention]
Adherence to physical activity aspect of intervention (including yoga)
Eligibility Criteria
Criteria
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;
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absence of suicidal ideations (measured as low risk on the M.I.N.I. Neuropsychiatric Interview tool);
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absence of pregnancy complications/physical conditions making physical activity (PA) inadvisable;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University School of Nursing | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Patricia A Kinser, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20006941
- 1R15HD086835-01A1