PostPartum Depression
Conditions
Keywords
Exercise, PostParum Depression
Brief summary
The purpose of this study is to examine the feasibility and efficacy of an exercise intervention for the prevention of postpartum depression. If efficacious, our intervention could be disseminated in real world settings in an effort to prevent postpartum depression.
Detailed description
Recent estimates indicate that approximately 10-15% of women giving birth experience depression during the postpartum period (Dietz et al., 2007; Gaven et al., 2005). Research indicates that psychological interventions are efficacious for treating postpartum depression (Dennis & Hodnett, 2007). However, it is important to also focus on the prevention of postpartum depression given many women do not seek treatment (Dennis & Chung-Lee, 2006) and those who do seek treatment may have already experienced negative consequences related to depression including cessation of breastfeeding and poor maternal-child bonding (Dennis & McQueen, 2007; Murray et al., 1999). Unfortunately, research indicates that psychological interventions are not efficacious in the prevention of postpartum depression among women at risk for postpartum depression (for a review see Dennis & Creedy, 2004). Consequently, there is a need to test new and innovative interventions for the prevention of postpartum depression. Exercise interventions have been shown to be effective for the treatment of depression among adults and therefore, this intervention may be efficacious in the prevention of postpartum depression. The purpose of the present pilot study is to examine the feasibility of recruiting and retaining participants at risk for postpartum depression for a randomized trial examining an exercise intervention for the prevention of postpartum depression. We will also examine the preliminary efficacy of the exercise intervention on the prevention of postpartum depression. Specifically, 120 sedentary, healthy pregnant women who have a history of at least one depressive episode and/or have a maternal family history of depression will be recruited from various ObGyn clinics, psychiatry clinics, and via advertisements. Once the potential participants receive healthcare provider consent to exercise (approximately two weeks following a vaginal delivery and four weeks following a c-section), participants will then be randomly assigned to either an exercise intervention or a health and wellness contact control condition. The exercise condition will consist of telephone-based counseling sessions designed to motivate postpartum women to become physically active. This theory-based intervention will be based on interventions shown to be effective in previous studies. The contact control condition will consist of scheduled telephone sessions with a health educator on issues related to health and wellness (e.g., stress reduction, sleep, nutrition). The specific aims of the study will be 1) to determine the feasibility of recruiting and retaining pregnant and postpartum women for an exercise intervention trial and 2) to determine the effect of a home-based behavioral exercise intervention on depression (as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I and the PHQ-9) among postpartum women. Physical activity adherence will be assessed using the 7-Day Physical Activity Recall Interview (Blair et al., 1985) and accelerometers (i.e., an objective assessment of physical activity).
Interventions
BEHAVIORALWellness Control
6-month wellness control
BEHAVIORALExercise Intervention
6 month exercise intervention
Sponsors
National Institute of Mental Health (NIMH)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* We will recruit healthy, sedentary (defined as exercising 60 minutes or less per week) women who are at least 18 years of age and at least 28 weeks pregnant or less than one month postpartum (n=120). Participants will be required to obtain written consent from their healthcare provider to participate. This written consent will be obtained following delivery of the newborn. Participants will complete a telephone screening interview to assess eligibility. Current depressive episode will be assessed using the PHQ-9 (cut-off will be 10 or higher). As we have done in previous trials, we will have a protocol in place that deals with participants expressing suicidal ideation ranging from referring them to their healthcare provider and/or calling emergency assistance, depending on intent. To be included, participants must be willing to be randomly assigned to either of the two study arms. Additionally, participants will read and sign a consent form approved by the University of Minnesota and have all of their questions will be answered prior to participating.
Exclusion criteria
* No healthcare provider consent to participate * Pre-existing hypertension or diabetes * Current participation in exercise (defined as exercising 60 or more minutes per week) * Currently enrolled in another exercise or weight management study * Less than 18 years of age * Another member of household participating in the study * Unable to speak, comprehend, read, or write fluently in the English language * Unable to walk for 30 minutes continuously * Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising * Exercise-induced asthma * Any condition that would make exercise unsafe or unwise * Taking medication that interferes with heart rate response to exercise such as beta blockers * Hospitalization for a psychiatric disorder in the past six months * Current depressive episode and/or currently receiving antidepressant medication or psychotherapy for depression (those who are depressed and who are not in treatment will be referred to their physician or psychiatrist for follow-up care) In addition to the initial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structured Clinical Interview for DSM-IV Axis I Disorders | 6 months | This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Physical Activity Recall Interview | 6 months | Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run). |
| Edinburgh Postnatal Depression Scale | 6 Months | This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression. |
| PHQ-9 | 6 Months | Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from January, 2010 through May, 2011 and follow-up assessments were completed by November, 2011. Participants were recruited via advertisements to the general public.
Pre-assignment details
The major reason for why participants who consented but did not participate was that they failed to return our telephone calls after they had their baby or we were unable to obtain physician consent for them to participate.
Participants by arm
| Arm | Count |
|---|---|
| Wellness Control Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control | 64 |
| Exercise Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control | 66 |
| Total | 130 |
Baseline characteristics
| Characteristic | Wellness Control | Exercise | Total |
|---|---|---|---|
| Age, Continuous | 31.39 years STANDARD_DEVIATION 4.63 | 31.69 years STANDARD_DEVIATION 5.27 | 31.54 years STANDARD_DEVIATION 4.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 64 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire (PHQ-9) | 6.56 units on a scale STANDARD_DEVIATION 4.27 | 5.42 units on a scale STANDARD_DEVIATION 3.28 | 5.99 units on a scale STANDARD_DEVIATION 3.83 |
| Perceived Stress Scale | 24.73 units on a scale STANDARD_DEVIATION 6.98 | 23.21 units on a scale STANDARD_DEVIATION 7.94 | 23.96 units on a scale STANDARD_DEVIATION 7.5 |
| Pittsburgh Sleep Quality Index | 7.11 units on a scale STANDARD_DEVIATION 3.08 | 7.11 units on a scale STANDARD_DEVIATION 2.61 | 7.11 units on a scale STANDARD_DEVIATION 2.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 55 Participants | 55 Participants | 110 Participants |
| Region of Enrollment United States | 64 participants | 66 participants | 130 participants |
| Sex/Gender, Customized Females | 64 participants | 66 participants | 130 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 130 | 0 / 130 |
| serious Total, serious adverse events | 0 / 64 | 0 / 66 |
Outcome results
Primary
Structured Clinical Interview for DSM-IV Axis I Disorders
This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wellness Control | Structured Clinical Interview for DSM-IV Axis I Disorders | 7.94 percentage of participants |
| Exercise | Structured Clinical Interview for DSM-IV Axis I Disorders | 8.20 percentage of participants |
Secondary
7-Day Physical Activity Recall Interview
Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Control | 7-Day Physical Activity Recall Interview | 123.3 Number of physical activity minutes | Standard Deviation 111.4 |
| Exercise | 7-Day Physical Activity Recall Interview | 129.8 Number of physical activity minutes | Standard Deviation 87.5 |
Secondary
Edinburgh Postnatal Depression Scale
This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Control | Edinburgh Postnatal Depression Scale | 7.02 Score on a scale | Standard Deviation 4.64 |
| Exercise | Edinburgh Postnatal Depression Scale | 4.69 Score on a scale | Standard Deviation 3.89 |
Secondary
PHQ-9
Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Control | PHQ-9 | 5.22 Score on a scale | Standard Deviation 4.59 |
| Exercise | PHQ-9 | 3.08 Score on a scale | Standard Deviation 3.04 |