Feasibility Evaluation of a Dance Fitness Program

February 15, 2024 updated by: Tracy Hellem, Montana State University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

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.

Study Contact

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group dance fitness, OULA
Mind-body dance fitness group
Other: OULA, Mind-body Physical Activity
Group dance fitness program with focus on the mind-body connection
No Intervention: Waitlist Control
Waitlist control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postpartum depression
Time Frame: 7 months
The Edinburgh Postnatal Depression Scale will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum depression.
7 months
Changes in postpartum anxiety
Time Frame: 7 months
Postpartum Specific Anxiety Scale Research Short Form will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum anxiety.
7 months

Collaborators and Investigators

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

Sponsor

Montana State University

Investigators

  • Principal Investigator: Tracy Hellem, PhD, Montana State University

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)

October 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OULA for Postpartum Depression

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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