Exercise and Socialization in Post-partum Depression

May 22, 2025 updated by: Laura Peterson-Brown

Post-partum Depression in Kentucky: A Community Based Intervention and a Novel AI-powered Screening Tool

This community-engaged research project aims to address the critical need for alternative treatments of post-partum depression (PPD). The goal of this research is to investigate the efficacy of a novel 8-week intervention combing exercise with social support to reduce PPD symptoms. It is hypothesized that exercise in addition to social support will more effectively reduce PPD symptom severity compared to social support alone. By collaborating with PPD mothers, clinicians, researchers, and local fitness instructors, the researchers aim to develop an intervention that is accessible, culturally appropriate, effective, and increases treatment adherence. Additionally, the researchers will investigate if mother-infant interactions during exercise can enhance bonding, thereby reducing the detrimental effects of maternal PPD on their off-spring.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over the age of 18 years old
  • Two-weeks to 12 months post-partum
  • EPDS over 10
  • Read and Speak English
  • Willing to supply contact information for their clinician and consent to their clinician being contacted in the event their depression worsens.

Exclusion Criteria:

  • Use of anti-depression medication(s) at time of enrollment
  • Unable to give consent
  • Prisoner, parolee, state probationer, or awaiting sentence for a felony conviction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Socialization only
Behavioral: Socialization
Socialization lasting from 30-60 minutes each session
Active Comparator: Socialization and walking
Behavioral: Socialization
Socialization lasting from 30-60 minutes each session
Behavioral: Walking
Twice weekly walking (30 minutes)
Active Comparator: Socialization and moderate exercise
Behavioral: Socialization
Socialization lasting from 30-60 minutes each session
Behavioral: Moderate Exercise
Twice weekly moderate exercise (30 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Edinburgh Post-natal Depression Scale (EPDS) score
Time Frame: Baseline, 4 weeks, 8 weeks

EPDS scores range between 0 and 30.

EDPS depression ranking system:

  • 0 to 6: No depression or minimal depression
  • 7 to 13: Mild depression
  • 14 to 19: Moderate Depression
  • 20 to 30: Severe Depression
Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mother-Infant Bonding Questionnaire (MIBQ) score
Time Frame: Baseline, 4 weeks, 8 weeks
MIBQ scores are between 0 and 24. Higher score indicates poor mother-baby bonding.
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laura Peterson-Brown

Investigators

  • Principal Investigator: Laura P Brown, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 28, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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