Postpartum Depression
Conditions
Keywords
Exercise, Postpartum Depression, Physical activity, eHealth intervention
Brief summary
The purpose of this study is to test whether a web-based (eHealth) exercise intervention for new moms at increased risk for postpartum depression increases physical activity and decreases postpartum depression symptoms.
Detailed description
Postpartum depression is a debilitating and costly condition that is associated with significant health consequences for mothers and children. Counseling for prevention of postpartum depression is currently recommended in women at high risk of postpartum depression; however, there is a shortage of mental health care providers. There is a need for effective interventions to prevent postpartum depression that can be easily integrated into health care systems, yet do not involve intense health care system resources. eHealth interventions are promising in this regard. Strong evidence suggests physical activity can reduce depression risk. This study will assess the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for increasing physical activity levels and improving depressive symptoms in women at increased risk of postpartum depression. This intervention addresses several identified barriers to physical activity in postpartum women. The study will randomize 200 women to receive an eHealth exercise intervention for postpartum women or usual postpartum care. Device-based physical activity and depressive symptoms will be measured at 3 and 6 months after randomization.
Interventions
BEHAVIORALExercise intervention
eHealth exercise intervention for postpartum women at increased risk of depression
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* KPNC member between 2 and 6 months postpartum * Current PHQ-8 score between 10-20 and no current depression diagnosis * Delivered baby in KPNC * English-speaking * Own a smartphone, computer, or TV with internet access * Free of a heart condition and a physician recommending medically supervised physical activity * Body Mass Index (BMI) between 18.5 and 40 (kg/m2) * A baby weighing between 11-22 lbs
Exclusion criteria
* Engaged in regular, moderate or vigorous physical activity \>90 minutes or more per week * Pregnant or planning to become pregnant in the ensuing three months * A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her * Chest pain during physical activity, or has had chest pain within the prior month * Taking medication for hypertension or a heart condition * Tendency to fall due to syncope or dizziness * Orthopedic problems that might be aggravated by physical activity * Has exercise-induced asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms | 3 months | Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression. |
| Device-Measured Physical Activity | 3 months | Actigraph-measured minutes of moderate/vigorous physical activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Physical Activity | 3 months | Self-reported moderate/vigorous physical activity |
| Device-measured Physical Activity | 6 months | Actigraph-measured minutes of moderate/vigorous physical |
| Depressive Symptoms | 6 months | Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep | 3 months | Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality. |
| Anxiety | 3 months | The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety. GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. |
| Mother-infant Bonding | 3 months | The Mother Infant Bonding Scale will be used to assess mother-infant bonding. Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding. |
| Stress | 3 months | Perceived stress will be measured using the Perceived Stress Scale (PSS-10). PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress. |
| Infant Development | At 12 months old | Ages and Stages questionnaire for 12-month-old infants. The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression | 50 |
| Usual Care Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention. | 49 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-month Follow up | Lost to Follow-up | 22 | 23 |
| 3-month Follow up | Withdrawal by Subject | 1 | 0 |
| 6-month Follow up | Lost to Follow-up | 5 | 2 |
| 6-month Follow up | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Intervention | Usual Care |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 4.8 | 31.9 years STANDARD_DEVIATION 5.1 | 32.7 years STANDARD_DEVIATION 4.5 |
| Depressive symptons | 12.6 score on a scale STANDARD_DEVIATION 2.2 | 12.6 score on a scale STANDARD_DEVIATION 2.2 | 12.6 score on a scale STANDARD_DEVIATION 2.2 |
| Months postpartum | 4.1 months STANDARD_DEVIATION 1.1 | 4.1 months STANDARD_DEVIATION 1.2 | 4 months STANDARD_DEVIATION 1 |
| Number of children at home 1 | 41 Participants | 20 Participants | 21 Participants |
| Number of children at home 2+ | 58 Participants | 30 Participants | 28 Participants |
| Physical activity level prior to pregnancy At or above recommendations | 39 Participants | 21 Participants | 18 Participants |
| Physical activity level prior to pregnancy Below recommendations | 60 Participants | 29 Participants | 31 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 10 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 22 Participants | 10 Participants | 12 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 37 Participants | 19 Participants | 18 Participants |
| Race/Ethnicity, Customized Other | 24 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Female | 99 Participants | 50 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Depression Symptoms
Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Time frame: 3 months
Population: After multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depression Symptoms | 10.1 score on a scale | Standard Deviation 5.4 |
| Usual Care | Depression Symptoms | 11 score on a scale | Standard Deviation 5.8 |
95% CI: [-3.3, 1.5]
Primary
Device-Measured Physical Activity
Actigraph-measured minutes of moderate/vigorous physical activity
Time frame: 3 months
Population: After multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Device-Measured Physical Activity | 53.2 minutes per day | Standard Deviation 39.9 |
| Usual Care | Device-Measured Physical Activity | 58 minutes per day | Standard Deviation 44.8 |
95% CI: [-23.5, 14.5]
Secondary
Depressive Symptoms
Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Time frame: 6 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depressive Symptoms | 7.9 score on a scale | Standard Deviation 4.9 |
| Usual Care | Depressive Symptoms | 9.1 score on a scale | Standard Deviation 5.4 |
95% CI: [-3.7, 1.1]
Secondary
Device-measured Physical Activity
Actigraph-measured minutes of moderate/vigorous physical
Time frame: 6 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Device-measured Physical Activity | 63.2 minutes per day | Standard Deviation 49.1 |
| Usual Care | Device-measured Physical Activity | 62.3 minutes per day | Standard Deviation 53.8 |
95% CI: [-18.9, 21.5]
Secondary
Self-reported Physical Activity
Self-reported moderate/vigorous physical activity
Time frame: 6 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Self-reported Physical Activity | 13.7 MET-hours per week | Standard Deviation 13.8 |
| Usual Care | Self-reported Physical Activity | 16.3 MET-hours per week | Standard Deviation 16.6 |
95% CI: [-7.7, 4.2]
Secondary
Self-reported Physical Activity
Self-reported moderate/vigorous physical activity
Time frame: 3 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Self-reported Physical Activity | 15.8 MET-hours per week | Standard Deviation 15.7 |
| Usual Care | Self-reported Physical Activity | 12.7 MET-hours per week | Standard Deviation 14.7 |
95% CI: [-1.9, 9.5]
Other Pre-specified
Anxiety
The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety. GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
Time frame: 3 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Anxiety | 9.2 score on a scale | Standard Deviation 5.4 |
| Usual Care | Anxiety | 10 score on a scale | Standard Deviation 5.7 |
95% CI: [-3.4, 1.2]
Other Pre-specified
Infant Development
Ages and Stages questionnaire for 12-month-old infants. The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
Time frame: At 12 months old
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Infant Development | Gross motor function | 47.6 score on a scale | Standard Deviation 15.1 |
| Intervention | Infant Development | Problem-solving | 42 score on a scale | Standard Deviation 12.9 |
| Intervention | Infant Development | Fine motor function | 50 score on a scale | Standard Deviation 9.4 |
| Intervention | Infant Development | Personal-social skills | 40.1 score on a scale | Standard Deviation 13.5 |
| Intervention | Infant Development | Communication | 44.6 score on a scale | Standard Deviation 13.9 |
| Usual Care | Infant Development | Personal-social skills | 36.9 score on a scale | Standard Deviation 14 |
| Usual Care | Infant Development | Communication | 42.1 score on a scale | Standard Deviation 14.7 |
| Usual Care | Infant Development | Gross motor function | 47.5 score on a scale | Standard Deviation 14.5 |
| Usual Care | Infant Development | Fine motor function | 48.5 score on a scale | Standard Deviation 9.5 |
| Usual Care | Infant Development | Problem-solving | 41.1 score on a scale | Standard Deviation 13.8 |
Other Pre-specified
Mother-infant Bonding
The Mother Infant Bonding Scale will be used to assess mother-infant bonding. Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.
Time frame: 3 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mother-infant Bonding | 1.7 score on a scale | Standard Deviation 2.9 |
| Usual Care | Mother-infant Bonding | 1.8 score on a scale | Standard Deviation 3 |
95% CI: [-1, 1.1]
Other Pre-specified
Sleep
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.
Time frame: 3 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Sleep | 9.6 score on a scale | Standard Deviation 4 |
| Usual Care | Sleep | 10.1 score on a scale | Standard Deviation 4.2 |
95% CI: [-1.2, 2.1]
Other Pre-specified
Stress
Perceived stress will be measured using the Perceived Stress Scale (PSS-10). PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.
Time frame: 3 months
Population: Intent to treat analysis with multiple imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Stress | 21 score on a scale | Standard Deviation 6.7 |
| Usual Care | Stress | 23.2 score on a scale | Standard Deviation 7.3 |
95% CI: [-4.9, 1.3]