The Effect of Exercise on Preventing PostPartum Depression
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 18, 2009 |
| Last Updated Date | April 24, 2013 |
| Start Date ICMJE | September 2009 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Structured Clinical Interview for DSM-IV Axis I Disorders [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00961402 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
7-Day Physical Activity Recall Interview [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Effect of Exercise on Preventing PostPartum Depression |
| Official Title ICMJE | Efficacy of an Exercise Intervention for the Prevention of PostPartum 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). |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | PostPartum Depression |
| Intervention ICMJE | Behavioral: Exercise
6-month exercise intervention vs. wellness control |
| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 130 |
| Completion Date | November 2011 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. |
| Gender | Female |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00961402 |
| Other Study ID Numbers ICMJE | R21 MH085176, R21MH085176, DAHBR A2-AID |
| Has Data Monitoring Committee | No |
| Responsible Party | University of Minnesota - Clinical and Translational Science Institute |
| Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute |
| Collaborators ICMJE | National Institute of Mental Health (NIMH) |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Minnesota - Clinical and Translational Science Institute |
| Verification Date | April 2013 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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