Postpartum DepressionNCT00384943
Study of Home-Based Exercise to Alleviate Postpartum Depression
A study testing Moderate-intensity Exercise in people with Postpartum Depression, run by McGill University at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of 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?
- Moderate-intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2001to Nov 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- women 4 to 38 weeks following childbirth
- score of 10 or more on the Edinburgh Postpartum Depression Scale
- understand English or French
- no current alcohol or substance abuse,
- not currently participating in regular moderate or high intensity exercise (30 minutes, at least 3 times per week)
Who cannot join
- obstetrical or concomitant diseases which would have precluded participation in an exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.
Read the detailed description
Postpartum depression occurs in 10-16% of women, with depressive symptoms lasting up to one year post delivery. Women affected by depression in the postpartum have been shown to be at higher risk for developing a recurrent depressive disorder. While the direct and indirect costs associated with postpartum depression are unknown, those associated with depression have been found to exceed 43 billion dollars in the United States alone. Moreover, maternal depression can negatively impact the mother-infant relationship and infant development. Despite the high prevalence of postpartum depression, the condition often goes undiagnosed and untreated by primary care providers. Alternative non-medical interventions for treating postpartum depression have not been widely investigated, leaving women and health care providers with few evidence-based options for treatment. If this exercise program is shown to be effective, then this intervention can be an alternate treatment option for alleviating depressed mood for women in the postpartum period. This nonpharmacological approach may be particularly attractive as many women are reluctant to take medication in the postpartum.
- Conditions
- Postpartum Depression
- Being tested
- Moderate-intensity Exercise
- Keywords
- postpartum depression, exercise
- 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.
Moderate-intensity ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
Secondary outcomes (1)
Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startNov 2001
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Investigators
- Deborah Da Costa, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384943
- Sponsor's protocol ID
- FRSQ 024018
- Status last verified
- Oct 2006
- First submitted
- 4 Oct 2006
- Last updated
- 6 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression
- ClinicalTrials.gov ID
- NCT00384943
- Acronym / sponsor ID
- FRSQ 024018
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- Nov 2001
- Study completion
- Nov 2004
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
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 evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.
Detailed description
Postpartum depression occurs in 10-16% of women, with depressive symptoms lasting up to one year post delivery. Women affected by depression in the postpartum have been shown to be at higher risk for developing a recurrent depressive disorder. While the direct and indirect costs associated with postpartum depression are unknown, those associated with depression have been found to exceed 43 billion dollars in the United States alone. Moreover, maternal depression can negatively impact the mother-infant relationship and infant development. Despite the high prevalence of postpartum depression, the condition often goes undiagnosed and untreated by primary care providers. Alternative non-medical interventions for treating postpartum depression have not been widely investigated, leaving women and health care providers with few evidence-based options for treatment. If this exercise program is shown to be effective, then this intervention can be an alternate treatment option for alleviating depressed mood for women in the postpartum period. This nonpharmacological approach may be particularly attractive as many women are reluctant to take medication in the postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women 4 to 38 weeks following childbirth
- score of 10 or more on the Edinburgh Postpartum Depression Scale
- understand English or French
- no current alcohol or substance abuse,
- not currently participating in regular moderate or high intensity exercise (30 minutes, at least 3 times per week)
Key exclusion criteria (1 listed)
- obstetrical or concomitant diseases which would have precluded participation in an exercise program.
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 |
|---|---|---|
| Moderate-intensity Exercise | Behavioural | – |
Primary outcome
Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
1 secondary outcome
Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2006.
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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.
Deborah Da Costa, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity Exercise in people with Postpartum Depression, run by McGill University at 1 site in Canada.
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 5 inclusion and 1 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 6 Oct 2006. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2006.