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

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

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 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

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883479


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Beth A Lewis, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01883479     History of Changes
Other Study ID Numbers: R01MH096748 ( U.S. NIH Grant/Contract )
R01MH096748 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications