Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression (HM2)

• ClinicalTrials.gov Identifier: NCT01883479
• Recruitment Status: Completed
• First Posted: June 21, 2013
• Last Update Posted: June 29, 2017
• Sponsor: University of Minnesota
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postpartum Depression	Behavioral: Exercise; Behavioral: Wellness/Support	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.
• Study Start Date: December 2012
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise; Telephone-based intervention designed to increase exercise among postpartum women.	Behavioral: Exercise; Telephone-based intervention designed to increase exercise among postpartum women.
Experimental: Wellness/Support; Telephone-based intervention designed to provide support to postpartum women.	Behavioral: Wellness/Support; Telephone-based intervention designed to provide support to postpartum women.
No Intervention: Usual care; Participants receive usual care and will receive their choice of the interventions at 9 months.

Outcome Measures

Primary Outcome Measures :

1. Depression [ Time Frame: 6 months ]
   Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I

Secondary Outcome Measures :

1. Depressive Symptoms [ Time Frame: 6 months ]
   Depressive symptoms as assessed by the PHQ-9

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Minnesota

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

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01883479
• Other Study ID Numbers: R01MH096748 ( U.S. NIH Grant/Contract ); R01MH096748 ( U.S. NIH Grant/Contract )
• First Posted: June 21, 2013
• Last Update Posted: June 29, 2017
• Last Verified: June 2017

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications