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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological mechanisms underlying the relationships among these psychosocial risk factors for PPD, and the development of PPD, remain unclear. However, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. The primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women with no history of depression | Non-Probability Sample of women with no history of depression | ||
| women with a past depression history | Non-Probability Sample of women with a past history of depression |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the study protocol during the prenatal phase. Feasibility will be defined by the successful completion of enrollment and stress testing lab visits in 13 out of the 15 participants designed per group. | 20-22 weeks gestation through 22-24 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility with respect to the ability to retain participants / avoid attrition, which will be defined as having at least 90% of participants who completed the prenatal phase of the study, also complete one of the postpartum phone interviews. | Phone interviews will be administered at 8 weeks and 12 weeks postpartum. | |
| The investigators will test for group differences, between women with or without depression histories, in stress reactivity of cortisol [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm. |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample of pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Shannon K Crowley, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Susan S Girdler, PhD | University of North Carolina, Chapel Hill | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Serum, Plasma, Adrenocorticotropic hormone (ACTH), Cortisol
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in stress reactivity of cortisol [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm. |
| The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24 |
| The investigators will test for group differences, between women with or without depression histories, in stress reactivity of adrenocorticotropic hormone ACTH [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm. | The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in stress reactivity of adrenocorticotropic hormone (ACTH) [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm. | The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24 |
| The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal depressive symptoms using the Endinburgh Postnatal Depression Scale (EPDS). | The Endinburgh Postnatal Depression Scale (EPDS) will be administered during the enrollment visit, scheduled during gestational weeks 20-22. |
| The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal anxious symptoms using the Spielberger State-Trait Anxiety Inventory (STAI), trait version. | The trait version of the Spielberger State-Trait Anxiety Inventory (STAI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22. |
| The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in recent stressful life events (last 6 months) using the Life Events Scale (LES). | The Life Events Scale (LES) will be administered during the enrollment visit, scheduled during gestational weeks 20-22. |
| The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal sleep quality (past 30 days) using the Pittsburgh Sleep Quality Index (PSQI). | The Pittsburgh Sleep Quality Index (PSQI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22. |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |