The Effect of Exercise on Preventing PostPartum Depression

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00961402
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 130
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PostPartum Depression	Behavioral: Wellness Control; Behavioral: Exercise Intervention	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of an Exercise Intervention for the Prevention of PostPartum Depression
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wellness Control Participants will receive health and wellness information and no exercise information.	Behavioral: Wellness Control; 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.	Behavioral: Exercise Intervention; 6 month exercise intervention

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Beth A Lewis, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00961402
• Other Study ID Numbers: 0903S61462; R21MH085176
• First Posted: Aug 19, 2009
• Last Update Posted: Nov 18, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Minnesota: Exercise; PostParum Depression
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

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 Detail	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.

Arm/Group Title	Wellness Control	Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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
Period Title: Overall Study
STARTED	64	66
Randomized	64	66
COMPLETED	63	61
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Wellness Control	Exercise	Total
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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	Total of all reporting groups
Overall Participants	64	66	130
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.39 (4.63)	31.69 (5.27)	31.54 (4.95)
Sex/Gender, Customized (participants) [Number]
Females	64 100%	66 100%	130 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4.7%	2 3%	5 3.8%
Not Hispanic or Latino	61 95.3%	64 97%	125 96.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 3%	2 1.5%
Asian	4 6.3%	1 1.5%	5 3.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 4.7%	6 9.1%	9 6.9%
White	55 85.9%	55 83.3%	110 84.6%
More than one race	2 3.1%	2 3%	4 3.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	64 100%	66 100%	130 100%
Perceived Stress Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.73 (6.98)	23.21 (7.94)	23.96 (7.50)
Patient Health Questionnaire (PHQ-9) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.56 (4.27)	5.42 (3.28)	5.99 (3.83)
Pittsburgh Sleep Quality Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.11 (3.08)	7.11 (2.61)	7.11 (2.84)

Outcome Measures

1. Primary Outcome

Title	Structured Clinical Interview for DSM-IV Axis I Disorders
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wellness Control	Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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
Measure Participants	63	61
Number [percentage of participants]	7.94 12.4%	8.20 12.4%

2. Secondary Outcome

Title	7-Day Physical Activity Recall Interview
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wellness Control	Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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
Measure Participants	63	61
Mean (Standard Deviation) [Number of physical activity minutes]	123.3 (111.4)	129.8 (87.5)

3. Secondary Outcome

Title	Edinburgh Postnatal Depression Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wellness Control	Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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
Measure Participants	63	61
Mean (Standard Deviation) [Score on a scale]	7.02 (4.64)	4.69 (3.89)

4. Secondary Outcome

Title	PHQ-9
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wellness Control	Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	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
Measure Participants	63	61
Mean (Standard Deviation) [Score on a scale]	5.22 (4.59)	3.08 (3.04)

Adverse Events

Arm/Group Title	Wellness Control		Exercise
Arm/Group Description	Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control		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
All Cause Mortality
	Wellness Control		Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Wellness Control		Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Wellness Control		Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/130 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.