Depression
Conditions
Keywords
Pregnancy, Self-Management, Yoga
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).
Interventions
BEHAVIORALMOMS Program
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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).
Exclusion criteria
* If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Data | baseline | \# individuals who enrolled in study/ # individuals who expressed interest in the study |
| Retention Data | 18 weeks post-baseline | \# of participants enrolled/ # of participants completing study |
| Adherence | End of 12 week intervention | Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters) |
| Completed Interviews | End of 6 week postpartum visit | The number of participants who completed the intervention and completed a postpartum semi-structured interview |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baby's Birth Weight | postpartum visit | Baby's birth weight in pounds per mother's report at postpartum visit |
| 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. |
| Total # of Minutes in Physical Activity (Including Yoga) | End of 12 week intervention | Adherence to physical activity aspect of intervention (including yoga) |
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | MOMS Program |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 29.10 years STANDARD_DEVIATION 5.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Adherence
Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Time frame: End of 12 week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOMS Program | Adherence | 26 Participants |
Primary
Completed Interviews
The number of participants who completed the intervention and completed a postpartum semi-structured interview
Time frame: End of 6 week postpartum visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOMS Program | Completed Interviews | 26 Participants |
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.
Time frame: baseline and end of 12 week intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Edinburgh Postnatal Depression Scale (EPDS) | Baseline | 15.2 score on a scale | Standard Deviation 0.86 |
| MOMS Program | Edinburgh Postnatal Depression Scale (EPDS) | End of Intervention | 5.05 score on a scale | Standard Deviation 0.67 |
Primary
Recruitment Data
\# individuals who enrolled in study/ # individuals who expressed interest in the study
Time frame: baseline
Population: 41 enrolled/ 50 eligible
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOMS Program | Recruitment Data | 41 Participants |
Primary
Retention Data
\# of participants enrolled/ # of participants completing study
Time frame: 18 weeks post-baseline
Population: 41 enrolled/ 27 completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOMS Program | Retention Data | 27 Participants |
Secondary
Baby's Birth Weight
Baby's birth weight in pounds per mother's report at postpartum visit
Time frame: postpartum visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOMS Program | Baby's Birth Weight | 7.57 pounds | Standard Deviation 1.33 |
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.
Time frame: baseline and at the end of the 12 week intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Maternal Fetal Attachment Scale (MFAS) | Baseline | 54.56 score on a scale | Standard Deviation 2.51 |
| MOMS Program | Maternal Fetal Attachment Scale (MFAS) | End of intervention | 43.97 score on a scale | Standard Deviation 2.01 |
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.
Time frame: baseline and end of 12 week intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Patient Health Questionnaire-9 (PHQ9) | Baseline | 13.54 score on a scale | Standard Deviation 0.4 |
| MOMS Program | Patient Health Questionnaire-9 (PHQ9) | End of intervention | 5.05 score on a scale | Standard Deviation 0.67 |
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.
Time frame: baseline and at the end of the 12 week intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Ruminations Response Scale (RRS-10) | Baseline | 26.63 score on a scale | Standard Deviation 1.08 |
| MOMS Program | Ruminations Response Scale (RRS-10) | End of intervention | 23.14 score on a scale | Standard Deviation 1.29 |
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
Time frame: Baseline visit to end of 12 week intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Self-Efficacy for Physical Activity | baseline | 26.04 score on a scale | Standard Deviation 7.4 |
| MOMS Program | Self-Efficacy for Physical Activity | end of intervention | 28.6 score on a scale | Standard Deviation 7.8 |
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.
Time frame: baseline and at the end of the 12 week intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | State-Trait Anxiety Inventory-State (STAI-S) | Baseline | 50.02 score on a scale | Standard Deviation 2.1 |
| MOMS Program | State-Trait Anxiety Inventory-State (STAI-S) | End of intervention | 36.04 score on a scale | Standard Deviation 2.1 |
Secondary
Stress
Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress
Time frame: Change from Baseline visit to end of 12 week intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOMS Program | Stress | Baseline | 25.27 score on a scale | Standard Deviation 0.89 |
| MOMS Program | Stress | End of intervention | 16.72 score on a scale | Standard Deviation 1.17 |
Secondary
Total # of Minutes in Physical Activity (Including Yoga)
Adherence to physical activity aspect of intervention (including yoga)
Time frame: End of 12 week intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MOMS Program | Total # of Minutes in Physical Activity (Including Yoga) | 141 minutes per week |