Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression (HM2)
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Wellness/Support
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Depression
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)
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Exercise
Wellness/Support
Usual care
Arm Description
Telephone-based intervention designed to increase exercise among postpartum women.
Telephone-based intervention designed to provide support to postpartum women.
Participants receive usual care and will receive their choice of the interventions at 9 months.
Outcomes
Primary Outcome Measures
Depression
Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I
Secondary Outcome Measures
Depressive Symptoms
Depressive symptoms as assessed by the PHQ-9
Full Information
NCT ID
NCT01883479
First Posted
April 24, 2013
Last Updated
June 28, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01883479
Brief Title
Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression
Acronym
HM2
Official Title
Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Telephone-based intervention designed to increase exercise among postpartum women.
Arm Title
Wellness/Support
Arm Type
Experimental
Arm Description
Telephone-based intervention designed to provide support to postpartum women.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants receive usual care and will receive their choice of the interventions at 9 months.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Telephone-based intervention designed to increase exercise among postpartum women.
Intervention Type
Behavioral
Intervention Name(s)
Wellness/Support
Intervention Description
Telephone-based intervention designed to provide support to postpartum women.
Primary Outcome Measure Information:
Title
Depression
Description
Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
Depressive symptoms as assessed by the PHQ-9
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth A Lewis, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34802425
Citation
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.
Results Reference
derived
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Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression
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