Self-Management of Chronic Depressive Symptoms in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 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).
排除标准
- •If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
研究组 & 干预措施
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.
干预措施: MOMS Program (Behavioral)
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: baseline and end of 12 week intervention
Pregnancy-specific Depressive Symptoms/Perinatal-specific depressive symptoms were measured by the 10-item Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987); scores range from0 to 30, and a score of≥10 is considered indicative of possible depressive symptoms.
Adherence
时间窗: End of 12 week intervention
Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Completed Interviews
时间窗: End of 6 week postpartum visit
The number of participants who completed the intervention and completed a postpartum semi-structured interview
Recruitment Data
时间窗: baseline
\# individuals who enrolled in study/ # individuals who expressed interest in the study
Retention Data
时间窗: 18 weeks post-baseline
\# of participants enrolled/ # of participants completing study
次要结局
- State-Trait Anxiety Inventory-State (STAI-S)(baseline and at the end of the 12 week intervention)
- Self-Efficacy for Physical Activity(Baseline visit to end of 12 week intervention visit)
- Stress(Change from Baseline visit to end of 12 week intervention visit)
- Total # of Minutes in Physical Activity (Including Yoga)(End of 12 week intervention)
- Patient Health Questionnaire-9 (PHQ9)(baseline and end of 12 week intervention)
- Maternal Fetal Attachment Scale (MFAS)(baseline and at the end of the 12 week intervention)
- Ruminations Response Scale (RRS-10)(baseline and at the end of the 12 week intervention)
- Baby's Birth Weight(postpartum visit)