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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15HD086835-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOMS Program | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOMS Program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Data | # individuals who enrolled in study/ # individuals who expressed interest in the study | baseline |
| Retention Data | # of participants enrolled/ # of participants completing study | 18 weeks post-baseline |
| Adherence | Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters) | End of 12 week intervention |
| Completed Interviews | The number of participants who completed the intervention and completed a postpartum semi-structured interview | End of 6 week postpartum visit |
| Edinburgh Postnatal Depression Scale (EPDS) | 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. | baseline and end of 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ9) | 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. | baseline and end of 12 week intervention |
| State-Trait Anxiety Inventory-State (STAI-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Kinser, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University School of Nursing | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33630532 | Derived | Kinser PA, Thacker LR, Rider A, Moyer S, Amstadter AB, Mazzeo SE, Bodnar-Deren S, Starkweather A. Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Nurs Res. 2021 Mar-Apr 01;70(2):95-105. doi: 10.1097/NNR.0000000000000485. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. MOMS Program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. MOMS Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Data | # individuals who enrolled in study/ # individuals who expressed interest in the study | 41 enrolled/ 50 eligible | Posted | Count of Participants | Participants | baseline |
|
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. MOMS Program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kinser, PI | Virginia Commonwealth University School of Nursing | 804-828-0724 | kinserpa@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2018 | Nov 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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State Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety. |
| baseline and at the end of the 12 week intervention |
| Ruminations Response Scale (RRS-10) | Ruminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination. | baseline and at the end of the 12 week intervention |
| Self-Efficacy for Physical Activity | 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 | Baseline visit to end of 12 week intervention visit |
| Maternal Fetal Attachment Scale (MFAS) | 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. | baseline and at the end of the 12 week intervention |
| Baby's Birth Weight | Baby's birth weight in pounds per mother's report at postpartum visit | postpartum visit |
| Stress | Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress | Change from Baseline visit to end of 12 week intervention visit |
| Total # of Minutes in Physical Activity (Including Yoga) | Adherence to physical activity aspect of intervention (including yoga) | End of 12 week intervention |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Retention Data | # of participants enrolled/ # of participants completing study | 41 enrolled/ 27 completed | Posted | Count of Participants | Participants | 18 weeks post-baseline |
|
|
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| Primary | Adherence | Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters) | Posted | Count of Participants | Participants | End of 12 week intervention |
|
|
|
| Primary | Completed Interviews | The number of participants who completed the intervention and completed a postpartum semi-structured interview | Posted | Count of Participants | Participants | End of 6 week postpartum visit |
|
|
|
| Primary | Edinburgh Postnatal Depression Scale (EPDS) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and end of 12 week intervention |
|
|
|
| Secondary | Patient Health Questionnaire-9 (PHQ9) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and end of 12 week intervention |
|
|
|
| Secondary | State-Trait Anxiety Inventory-State (STAI-S) | State Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety. | Posted | Mean | Standard Deviation | score on a scale | baseline and at the end of the 12 week intervention |
|
|
|
| Secondary | Ruminations Response Scale (RRS-10) | Ruminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination. | Posted | Mean | Standard Deviation | score on a scale | baseline and at the end of the 12 week intervention |
|
|
|
| Secondary | Self-Efficacy for Physical Activity | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline visit to end of 12 week intervention visit |
|
|
|
| Secondary | Maternal Fetal Attachment Scale (MFAS) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and at the end of the 12 week intervention |
|
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| Secondary | Baby's Birth Weight | Baby's birth weight in pounds per mother's report at postpartum visit | Posted | Mean | Standard Deviation | pounds | postpartum visit |
|
|
|
| Secondary | Stress | Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline visit to end of 12 week intervention visit |
|
|
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| Secondary | Total # of Minutes in Physical Activity (Including Yoga) | Adherence to physical activity aspect of intervention (including yoga) | Posted | Mean | Full Range | minutes per week | End of 12 week intervention |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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