Exercise and Socialization in Post-partum Depression

NCT06801847 | Withdrawn

• 1 other identifier: 99825
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• Change in Edinburgh Post-natal Depression Scale (EPDS) score

  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 Outcomes (1)

• Change in Mother-Infant Bonding Questionnaire (MIBQ) score

  Baseline, 4 weeks, 8 weeks

Study Arms (3)

Socialization only

ACTIVE COMPARATOR

Behavioral: Socialization

Socialization and walking

ACTIVE COMPARATOR

Behavioral: Socialization; Behavioral: Walking

Socialization and moderate exercise

ACTIVE COMPARATOR

Behavioral: Socialization; Behavioral: Moderate Exercise

Interventions

Socialization BEHAVIORAL

Socialization lasting from 30-60 minutes each session

Socialization and moderate exercise; Socialization and walking; Socialization only

Walking BEHAVIORAL

Twice weekly walking (30 minutes)

Socialization and walking

Moderate Exercise BEHAVIORAL

Twice weekly moderate exercise (30 minutes)

Socialization and moderate exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Peterson-Brown: lead

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Walking

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Laura P Brown, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post-Doc Scholar

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: March 28, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share