- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961402
The Effect of Exercise on Preventing PostPartum Depression
October 30, 2019 updated by: University of Minnesota
Efficacy of an Exercise Intervention for the Prevention of PostPartum Depression
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 exclusion criteria listed above, we will withdraw the exercise intervention and instruct the participant to contact their healthcare provider if the participant develops a medical issue in which exercise would be unsafe.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wellness Control
Participants will receive health and wellness information and no exercise information.
|
6-month wellness control
|
Experimental: Exercise Intervention
Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
|
6 month exercise intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Structured Clinical Interview for DSM-IV Axis I Disorders
Time Frame: 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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-Day Physical Activity Recall Interview
Time Frame: 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).
|
6 months
|
Edinburgh Postnatal Depression Scale
Time Frame: 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.
|
6 Months
|
PHQ-9
Time Frame: 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
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Beth A Lewis, PhD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lewis BA, Gjerdingen D, Schuver K, Avery M, Marcus BH. The effect of sleep pattern changes on postpartum depressive symptoms. BMC Womens Health. 2018 Jan 9;18(1):12. doi: 10.1186/s12905-017-0496-6.
- Lewis BA, Billing L, Schuver K, Gjerdingen D, Avery M, Marcus BH. The relationship between employment status and depression symptomatology among women at risk for postpartum depression. Womens Health (Lond). 2017 Apr;13(1):3-9. doi: 10.1177/1745505717708475. Epub 2017 May 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Actual)
November 18, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0903S61462
- R21MH085176 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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