Trial Outcomes & Findings for Self-Management of Chronic Depressive Symptoms in Pregnancy (NCT NCT02953990)
NCT ID: NCT02953990
Last Updated: 2024-03-25
Results Overview
\# individuals who enrolled in study/ # individuals who expressed interest in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline
Results posted on
2024-03-25
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Management of Chronic Depressive Symptoms in Pregnancy
Baseline characteristics by cohort
| Measure |
MOMS Program
n=41 Participants
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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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.10 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 41 enrolled/ 50 eligible
\# individuals who enrolled in study/ # individuals who expressed interest in the study
Outcome measures
| Measure |
MOMS Program
n=50 Participants
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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|---|---|
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Recruitment Data
|
41 Participants
|
PRIMARY outcome
Timeframe: 18 weeks post-baselinePopulation: 41 enrolled/ 27 completed
\# of participants enrolled/ # of participants completing study
Outcome measures
| Measure |
MOMS Program
n=41 Participants
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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Retention Data
|
27 Participants
|
PRIMARY outcome
Timeframe: End of 12 week interventionMeasure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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Adherence
|
26 Participants
|
PRIMARY outcome
Timeframe: End of 6 week postpartum visitThe number of participants who completed the intervention and completed a postpartum semi-structured interview
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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Completed Interviews
|
26 Participants
|
PRIMARY outcome
Timeframe: baseline and end of 12 week interventionPregnancy-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.
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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
|
|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS)
Baseline
|
15.2 score on a scale
Standard Deviation 0.86
|
|
Edinburgh Postnatal Depression Scale (EPDS)
End of Intervention
|
5.05 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: baseline and end of 12 week interventionDepressive 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.
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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
|
|---|---|
|
Patient Health Questionnaire-9 (PHQ9)
Baseline
|
13.54 score on a scale
Standard Deviation 0.40
|
|
Patient Health Questionnaire-9 (PHQ9)
End of intervention
|
5.05 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: baseline and at the end of the 12 week interventionState Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety.
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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State-Trait Anxiety Inventory-State (STAI-S)
Baseline
|
50.02 score on a scale
Standard Deviation 2.10
|
|
State-Trait Anxiety Inventory-State (STAI-S)
End of intervention
|
36.04 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: baseline and at the end of the 12 week interventionRuminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination.
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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Ruminations Response Scale (RRS-10)
Baseline
|
26.63 score on a scale
Standard Deviation 1.08
|
|
Ruminations Response Scale (RRS-10)
End of intervention
|
23.14 score on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline visit to end of 12 week intervention visitSelf-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
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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Self-Efficacy for Physical Activity
baseline
|
26.04 score on a scale
Standard Deviation 7.4
|
|
Self-Efficacy for Physical Activity
end of intervention
|
28.6 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: baseline and at the end of the 12 week interventionMaternal-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.
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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|---|---|
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Maternal Fetal Attachment Scale (MFAS)
Baseline
|
54.56 score on a scale
Standard Deviation 2.51
|
|
Maternal Fetal Attachment Scale (MFAS)
End of intervention
|
43.97 score on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: postpartum visitBaby's birth weight in pounds per mother's report at postpartum visit
Outcome measures
| Measure |
MOMS Program
n=21 Participants
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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|---|---|
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Baby's Birth Weight
|
7.57 pounds
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Change from Baseline visit to end of 12 week intervention visitPerceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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|---|---|
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Stress
Baseline
|
25.27 score on a scale
Standard Deviation 0.89
|
|
Stress
End of intervention
|
16.72 score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: End of 12 week interventionAdherence to physical activity aspect of intervention (including yoga)
Outcome measures
| Measure |
MOMS Program
n=27 Participants
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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|---|---|
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Total # of Minutes in Physical Activity (Including Yoga)
|
141 minutes per week
Interval 0.0 to 1070.0
|
Adverse Events
MOMS Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Kinser, PI
Virginia Commonwealth University School of Nursing
Phone: 804-828-0724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place