Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression

Postpartum Depression Clinical Trial

— HM2  

Official title:

Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883479
• Other study ID #: R01MH096748
• Secondary ID: R01MH096748
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: June 28, 2017
• Start date: December 2012
• Est. completion date: May 1, 2017

Study information

• Verified date: June 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Exercise
Telephone-based intervention designed to increase exercise among postpartum women.
• Wellness/Support
Telephone-based intervention designed to provide support to postpartum women.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I	6 months
Secondary	Depressive Symptoms	Depressive symptoms as assessed by the PHQ-9	6 months