Postpartum DepressionNCT06273423
Feasibility Evaluation of a Dance Fitness Program
A study testing OULA, Mind-body Physical Activity in people with Postpartum Depression, run by Montana State University.
Trial summary
The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD). Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- OULA, Mind-body Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ages 20-39 years
- Have an infant 0-12 months old
- Self-report clearance from provider to engage in physical activity following birth
- Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
- Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
- English speaking
- OULA-naïve
- If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks
Who cannot join
- Unable to be physically active
- Current pregnancy
- SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
- Active suicidal attempt or plan identified on the SCID-5-RV
- Suicide attempt in the past 6 months
- Concurrent participation in another group dance fitness format
- No access to Internet via computer, tablet, or smart phone
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Randomized Controlled Evaluation of a Mind-Body Dance Fitness Program for Improving Symptoms of Postpartum Depression
The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).
Read the detailed description
The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.
- Conditions
- Postpartum Depression
- Being tested
- OULA, Mind-body Physical Activity
- Keywords
- Postpartum, Depression, Mind-body, Physical activity
- Medical subject headings
- Depression, Postpartum, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OULA, Mind-body Physical ActivityOther
Group dance fitness program with focus on the mind-body connection
| Study group | Role | What they receive |
|---|---|---|
| Group dance fitness, OULA | Experimental | Mind-body dance fitness group Receives: Other: OULA, Mind-body Physical Activity |
| Waitlist Control | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability
Feasibility will be evaluated using recruitment, retention, OULA attendance, and treatment completion data, amd intervention fidelity. Feasibility of recruitment will be assessed through the number of participants eligible for randomization, proportion of participants randomized relative to the total number of referrals, and number of participants enrolled each month. Feasibility of intervention will be evaluated through treatment completion and retention rates, Feasibility of Intervention Measure (FIM) will be used at intervention completion. Fidelity assessment will be measured by OULA instructors completing an self-evaluation checklist. Women in the OULA group will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) will be collected at week 8. Acceptability will be assessed through reasons for withdrawal. Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) will be collected at week 8.
Measured: 7 months
Secondary outcomes (2)
Changes in postpartum depression
The Edinburgh Postnatal Depression Scale will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum depression.
Measured: 7 months
Changes in postpartum anxiety
Postpartum Specific Anxiety Scale Research Short Form will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum anxiety.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startOct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Hellem, Montana State University
- Investigators
- Tracy Hellem, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273423
- Sponsor's protocol ID
- OULA for Postpartum Depression
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in mind-body physical activity interventions for postpartum depression. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Controlled Evaluation of a Mind-Body Dance Fitness Program for Improving Symptoms of Postpartum Depression
- ClinicalTrials.gov ID
- NCT06273423
- Acronym / sponsor ID
- OULA for Postpartum Depression
- Conditions
- Postpartum Depression
- Keywords
- Postpartum, Depression, Mind-body, Physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).
Detailed description
The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group dance fitness, OULA | Experimental | Other: OULA, Mind-body Physical ActivityMind-body dance fitness group |
| Waitlist Control | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ages 20-39 years
- Have an infant 0-12 months old
- Self-report clearance from provider to engage in physical activity following birth
- Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
- Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
Key exclusion criteria (7 listed)
- Unable to be physically active
- Current pregnancy
- SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
- Active suicidal attempt or plan identified on the SCID-5-RV
- Suicide attempt in the past 6 months
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 |
|---|---|---|
| OULA, Mind-body Physical ActivityGroup dance fitness program with focus on the mind-body connection | Other | Group dance fitness, OULA |
Primary outcome
Feasibility and acceptability
Time frame: 7 months
Feasibility will be evaluated using recruitment, retention, OULA attendance, and treatment completion data, amd intervention fidelity. Feasibility of recruitment will be assessed through the number of participants eligible for randomization, proportion of participants randomized relative to the total number of referrals, and number of participants enrolled each month. Feasibility of intervention will be evaluated through treatment completion and retention rates, Feasibility of Intervention Measure (FIM) will be used at intervention completion. Fidelity assessment will be measured by OULA instructors completing an self-evaluation checklist. Women in the OULA group will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) will be collected at week 8. Acceptability will be assessed through reasons for withdrawal. Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) will be collected at week 8.
2 secondary outcomes
Changes in postpartum depression
Time frame: 7 months
Changes in postpartum anxiety
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in mind-body physical activity interventions for postpartum depression. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Tracy Hellem, PhD principal investigator
Montana State University
Questions about this trial
What is this clinical trial studying?
A study testing OULA, Mind-body Physical Activity in people with Postpartum Depression, run by Montana State University.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy Hellem, PhD (406-243-2110, tracy.hellem1@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability (time frame: 7 months). 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 22 Feb 2024.