Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression

NCT ID: NCT01883479

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-05-01

Brief Summary

The purpose of this study is to examine the efficacy of the active interventions (exercise or wellness/support intervention) compared to usual care on the prevention of postpartum depression among women at risk for depression. The investigators will also examine the efficacy of an exercise intervention compared to a wellness/support intervention on postpartum depressive symptoms among women at risk for depression.

Detailed Description

The purpose of this study is to examine the efficacy of exercise and wellness/support interventions for preventing postpartum depression. Specifically, 450 sedentary postpartum women (2-6 weeks postpartum) with a history of depression prior to pregnancy will be randomized to one of three groups each lasting six months: (1) telephone-based exercise intervention; (2) telephone-based wellness/support intervention; or (3) usual care. Participants will also complete a follow-up assessment session at 9 months. Participants will be recruited via online, email, and print advertisements. The investigators will obtain healthcare provider consent for each participant prior to randomization. The exercise intervention will consist of a theory-based telephone intervention shown to increase exercise among postpartum women in a previous study (Lewis et al., 2011). The wellness/support condition will be on the same schedule as the exercise intervention and will address several topics related to wellness. The usual care condition will receive their choice of the exercise or wellness/support condition upon completion of their final assessment. The primary dependent variable will be depression as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and the Edinburgh Postnatal Depression Scale (EPDS). Exercise adherence will be assessed using the 7-Day Physical Activity Recall Interview and the ActiGraph (i.e., an accelerometer, an objective measure of exercise).

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise

Telephone-based intervention designed to increase exercise among postpartum women.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Telephone-based intervention designed to increase exercise among postpartum women.

Wellness/Support

Telephone-based intervention designed to provide support to postpartum women.

Group Type: EXPERIMENTAL

Wellness/Support

Intervention Type: BEHAVIORAL

Telephone-based intervention designed to provide support to postpartum women.

Usual care

Participants receive usual care and will receive their choice of the interventions at 9 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Telephone-based intervention designed to increase exercise among postpartum women.

Intervention Type: BEHAVIORAL

Wellness/Support

Telephone-based intervention designed to provide support to postpartum women.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Generally healthy
• Low active
• Currently pregnant (who will wait to be randomized until postpartum) or less than six weeks postpartum
• History of depression

Exclusion Criteria

• Less than 18 years of age
• Pre-existing hypertension or diabetes
• Currently exercising (defined as exercising more than 60 minutes per week)
• Enrolled in another exercise or weight management study
• Another member of the household participating in the study
• Unable to exercise for 20 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 (based on the SCID) and/or currently receiving antidepressant medication or psychotherapy for depression (participants who are depressed prior to randomization will be referred to their primary physician or psychiatrist)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth A Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Lewis BA, Schuver K, Dunsiger S, Samson L, Frayeh AL, Terrell CA, Ciccolo JT, Fischer J, Avery MD. Randomized trial examining the effect of exercise and wellness interventions on preventing postpartum depression and perceived stress. BMC Pregnancy Childbirth. 2021 Nov 22;21(1):785. doi: 10.1186/s12884-021-04257-8.

Reference Type: DERIVED

PMID: 34802425 (View on PubMed)

Other Identifiers

R01MH096748

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH096748

Identifier Type: NIH

Identifier Source: org_study_id

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