Self-Management of Chronic Depressive Symptoms in Pregnancy
- Conditions
- Depression
- Interventions
- Behavioral: MOMS Program
- Registration Number
- NCT02953990
- Lead Sponsor
- Virginia Commonwealth University
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 41
- ≥ 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).
- If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MOMS Program 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.
- Primary Outcome Measures
Name Time Method Recruitment Data baseline # individuals who enrolled in study/ # individuals who expressed interest in the study
Edinburgh Postnatal Depression Scale (EPDS) 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 End of 12 week intervention Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Retention Data 18 weeks post-baseline # of participants enrolled/ # of participants completing study
Completed Interviews End of 6 week postpartum visit The number of participants who completed the intervention and completed a postpartum semi-structured interview
- Secondary Outcome Measures
Name Time Method State-Trait Anxiety Inventory-State (STAI-S) baseline and at the end of the 12 week intervention State Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety.
Self-Efficacy for Physical Activity Baseline visit to end of 12 week intervention visit Self-Efficacy for Physical Activity: The Physical Activity Self-Efficacy Scale is an eight-question scale that contains items about self-management of physical activities and social support regarding physical activity. A higher score indicates higher self-efficacy. The scores may range form 0-90
Stress Change from Baseline visit to end of 12 week intervention visit Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress
Total # of Minutes in Physical Activity (Including Yoga) End of 12 week intervention Adherence to physical activity aspect of intervention (including yoga)
Patient Health Questionnaire-9 (PHQ9) baseline and end of 12 week intervention Depressive Symptoms/ Perceived stress was measured with the 10-item Perceived Stress Scale; scores range from 0 to 40, and higher scores represent higher perceived stress.
Maternal Fetal Attachment Scale (MFAS) baseline and at the end of the 12 week intervention Maternal-Child Attachment/ Maternal-fetal/ child attachment was measured using the Maternal-Fetal Attachment Scale with wording adapted slightly for the postpartum use; scores range from 24 to 120,with higher scores indicating higher attachment.
Ruminations Response Scale (RRS-10) baseline and at the end of the 12 week intervention Ruminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination.
Baby's Birth Weight postpartum visit Baby's birth weight in pounds per mother's report at postpartum visit
Trial Locations
- Locations (1)
Virginia Commonwealth University School of Nursing
🇺🇸Richmond, Virginia, United States