Post Partum DepressionNCT06801847
Exercise and Socialization in Post-partum Depression
A study testing Socialization, Walking and Moderate Exercise in people with Post Partum Depression, run by Laura Peterson-Brown.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Socialization, Walking and Moderate Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Post Partum Depression
- Being tested
- Socialization, Walking, Moderate Exercise
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocializationBehavioural
Socialization lasting from 30-60 minutes each session
WalkingBehavioural
Twice weekly walking (30 minutes)
Moderate ExerciseBehavioural
Twice weekly moderate exercise (30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Socialization only | Active comparator | Not described Receives: Behavioral: Socialization |
| Socialization and walking | Active comparator | Not described Receives: Behavioral: Socialization; Behavioral: Walking |
| Socialization and moderate exercise | Active comparator | Not described Receives: Behavioral: Socialization; Behavioral: Moderate Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (1)
Change in Mother-Infant Bonding Questionnaire (MIBQ) score
MIBQ scores are between 0 and 24. Higher score indicates poor mother-baby bonding.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start28 Mar 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Peterson-Brown
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Peterson-Brown, University of Kentucky
- Investigators
- Laura P Brown, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801847
- Sponsor's protocol ID
- 99825
- Status last verified
- May 2025
- First submitted
- 24 Jan 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-partum Depression in Kentucky: A Community Based Intervention and a Novel AI-powered Screening Tool
- ClinicalTrials.gov ID
- NCT06801847
- Acronym / sponsor ID
- 99825
- Conditions
- Post Partum Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laura Peterson-BrownUniversity, hospital or other
- Study start
- 28 Mar 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SocializationSocialization lasting from 30-60 minutes each session | Behavioural | Socialization and moderate exercise, Socialization and walking, Socialization only |
| WalkingTwice weekly walking (30 minutes) | Behavioural | Socialization and walking |
| Moderate ExerciseTwice weekly moderate exercise (30 minutes) | Behavioural | Socialization and moderate exercise |
Primary outcome
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
1 secondary outcome
Change in Mother-Infant Bonding Questionnaire (MIBQ) score
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura P Brown, PhD principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
A study testing Socialization, Walking and Moderate Exercise in people with Post Partum Depression, run by Laura Peterson-Brown.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Edinburgh Post-natal Depression Scale (EPDS) score (time frame: Baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.