PostPartum DepressionPhase 2NCT00961402
The Effect of Exercise on Preventing PostPartum Depression
A Phase 2 study testing Exercise Intervention in people with PostPartum Depression, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PostPartum Depression
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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).
- Conditions
- PostPartum Depression
- Being tested
- Wellness Control, Exercise Intervention
- Keywords
- Exercise, PostParum Depression
- Medical subject headings
- Depression, Postpartum, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness ControlBehavioural
6-month wellness control
Exercise InterventionBehavioural
6 month exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Wellness Control | Experimental | Participants will receive health and wellness information and no exercise information. Receives: Behavioral: Wellness Control |
| Exercise Intervention | Experimental | Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 6 months
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.
Measured: 6 Months
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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PostPartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Beth A Lewis, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961402
- Sponsor's protocol ID
- 0903S61462
- Other IDs
- R21MH085176
- Status last verified
- Oct 2019
- First submitted
- 18 Aug 2009
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29316912Lewis 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.
PubMed 28480799
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Exercise Intervention for the Prevention of PostPartum Depression
- ClinicalTrials.gov ID
- NCT00961402
- Acronym / sponsor ID
- 0903S61462
- Conditions
- PostPartum Depression
- Keywords
- Exercise, PostParum Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness Control | Experimental | Behavioral: Wellness ControlParticipants will receive health and wellness information and no exercise information. |
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionIntervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Control6-month wellness control | Behavioural | Wellness Control |
| Exercise Intervention6 month exercise intervention | Behavioural | Exercise Intervention |
Primary outcome
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.
3 secondary outcomes
7-Day Physical Activity Recall Interview
Time frame: 6 months
Edinburgh Postnatal Depression Scale
Time frame: 6 Months
PHQ-9
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29316912Lewis 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.
- Derived from this study: PubMed 28480799Lewis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Lewis, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise Intervention in people with PostPartum Depression, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Clinical Interview for DSM-IV Axis I Disorders (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.